Ignite Creation Date:
2025-12-25 @ 4:02 AM
Ignite Modification Date:
2025-12-26 @ 2:55 AM
Study NCT ID:
NCT00336102
Status:
COMPLETED
Last Update Posted:
2015-07-09
First Post:
2006-06-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Thyroid Dysfunction in Women With Newly Diagnosed Breast Cancer Compared to Healthy Volunteers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}, {'id': 'D005221', 'term': 'Fatigue'}, {'id': 'D007037', 'term': 'Hypothyroidism'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D013959', 'term': 'Thyroid Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Markers of thyroid function including thyroid stimulating hormone (TSH), Free thyroxine (free T4) and Thyroid peroxidase antibody (TPO Ab). These will be performed at baseline, in 12 months and again 24 months after enrollment. All thyroid function marker assays will be performed by LabCorp.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 541}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-07', 'completionDateStruct': {'date': '2015-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-07-07', 'studyFirstSubmitDate': '2006-06-08', 'studyFirstSubmitQcDate': '2006-06-08', 'lastUpdatePostDateStruct': {'date': '2015-07-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-06-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Compare proportion of hypothyroidism in women with newly diagnosed stage I-IIIB breast cancer prior to chemotherapy vs in age-matched healthy volunteers', 'timeFrame': '2 years'}, {'measure': 'Compare change in thyroid function from baseline to 24 months after enrollment', 'timeFrame': '2 years'}], 'secondaryOutcomes': [{'measure': 'Correlate variation in thyroid function with fatigue symptom scores and anthropometric measurements at baseline and 24 months after enrollment', 'timeFrame': '2 years'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['fatigue', 'hypothyroidism', 'stage I breast cancer', 'stage II breast cancer', 'stage IIIA breast cancer', 'stage IIIB breast cancer'], 'conditions': ['Breast Cancer', 'Fatigue', 'Hypothyroidism']}, 'descriptionModule': {'briefSummary': 'RATIONALE: Learning about thyroid dysfunction in patients with breast cancer may help plan treatment and may help patients live more comfortably.\n\nPURPOSE: This clinical trial is studying how often thyroid dysfunction happens in women with newly diagnosed stage I, stage II, or stage III breast cancer who are planning to undergo chemotherapy compared to how often it happens in healthy volunteers.', 'detailedDescription': 'OBJECTIVES:\n\nPrimary\n\n* Compare the proportion of hypothyroidism in women with newly diagnosed stage I-IIIB breast cancer (prior to chemotherapy) vs in cancer-free, age-matched healthy volunteers.\n* Compare the magnitude of change in thyroid function in these patients from baseline to 24 months vs in cancer-free, age-matched healthy volunteers.\n\nSecondary\n\n* Correlate variation in thyroid function with fatigue symptom scores.\n* Correlate variation in thyroid function with anthropometric measurements.\n\nOUTLINE: This is a pilot, multicenter study.\n\nPatients and age-matched healthy volunteers undergo blood collection at baseline and at 12 and 24 months after enrollment. They also undergo anthropometric measurements and complete the Fatigue Symptom Inventory at baseline and at 12 and 24 months after enrollment.\n\nPROJECTED ACCRUAL: A total of 270 patients and 280 healthy volunteers will be accrued for this study.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '20 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "This is a pilot study with a planned accrual of 270 patients (cases) and 280 healthy volunteers (controls). Patients between the ages of 25 and 75, diagnosed with primary, operable, stage I-III B breast cancer with planned chemotherapy regimen Adriamycin / Cytoxan (AC) plus a taxane are trial candidates. Participants will be asked to nominate 2 women to serve as their healthy control. In the event the first woman is not eligible or decides not to participate, the second woman will be evaluated. Controls will be women from the same general demographic area, have no prior history of cancer and be within 5 years of the patient's age (+/- 5 years).", 'healthyVolunteers': True, 'eligibilityCriteria': "CASE SELECTION:\n\n* CASE INCLUSION CRITERIA:\n* Women between the ages of 25 and 75\n* Diagnosed with primary and operable Stage I - IIIB breast cancer\n* Scheduled to receive neoadjuvant or adjuvant Adriamycin and Cytoxan (AC) plus a taxane (taxane may be given with AC or follow AC)\n* No chemotherapy prior to baseline sample collection\n* No prior history of other cancers (except non-melanoma skin cancer)\n* Preoperative radiation therapy is permitted\n* No diagnosis of hypothyroidism or hyperthyroidism.\n* CASE EXCLUSION CRITERIA:\n* Stage IV breast cancer\n* Scheduled to receive neoadjuvant hormonal therapy (patients who will receive adjuvant hormonal therapy may participate)\n* Received adjuvant hormonal therapy or chemotherapy prior to sample collection\n* On chemotherapeutic regimen other than Adriamycin and Cytoxan plus a taxane.\n* Patients receiving monoclonal antibodies or other biologic therapy may not participate\n* Patients scheduled to receive Herceptin may not participate\n* Diagnosed with hyperthyroidism or hypothyroidism. (Women being treated for hypothyroidism are not eligible)\n* Women with a baseline TSH of 10 or higher will not continue on study\n* Women who are pregnant or lactating are not eligible. (Women of childbearing potential who are planning to become pregnant within the next 24 months should not enroll in this study)\n\nCONTROL SELECTION:\n\n* CONTROL INCLUSION CRITERIA:\n* Cannot be a blood relative of the case. They can be friends, neighbors, women from social activities, local business, doctors' offices, etc.\n* Must live near or in the town of the case\n* Women between the ages of 20 and 80 (age-matched to cases +/- 5 years)\n* No prior history of cancer (except non-melanoma skin cancer)\n* Women ages 40 and older should have had a mammogram within 2 years of study entry, showing no evidence of breast cancer.\n* The friend control may bring their mammogram report or send a release and have records faxed to the enrolling center.\n* Women under the age of 40 should have had a clinical breast examination within 2 years of study entry, showing no need for diagnostic mammography. If a mammogram was required, it should show no evidence of breast cancer.\n* The friend control may bring their mammogram / breast exam report or send a release and have records faxed to the enrolling center."}, 'identificationModule': {'nctId': 'NCT00336102', 'briefTitle': 'Thyroid Dysfunction in Women With Newly Diagnosed Breast Cancer Compared to Healthy Volunteers', 'organization': {'class': 'OTHER', 'fullName': 'University of South Florida'}, 'officialTitle': 'Thyroid Function & Breast Cancer: A Pilot Study to Estimate the Prevalence of Thyroid Dysfunction in Women Diagnosed With Breast Cancer and the Magnitude of Change in Thyroid Function Post-Chemotherapy', 'orgStudyIdInfo': {'id': 'SCUSF 0502'}, 'secondaryIdInfos': [{'id': 'SCUSF-0502', 'type': 'OTHER', 'domain': 'SunCoast CCOP Research Base'}, {'id': '5U10CA081920-11', 'link': 'https://reporter.nih.gov/quickSearch/5U10CA081920-11', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Group 1 Breast Cancer Patient Cases', 'description': 'Patients between the ages of 25 and 75, diagnosed with primary, operable, stage I-III B breast cancer with planned chemotherapy regimen Adriamycin / Cytoxan (AC) plus a taxane are trial candidates.\n\nWill have physiologic testing at baseline to assess thyroid function and fatigue assessment and management inventory. Will follow-up on management of therapy complications for thyroid disorder if one identified or until off study.', 'interventionNames': ['Other: physiologic testing', 'Procedure: fatigue assessment and management', 'Procedure: management of therapy complications']}, {'label': 'Group 2 Healthy Controls', 'description': "Controls will be women from the same general demographic area as Group 1 Cases, have no prior history of cancer and be within 5 years of the Group 1 case's age (+/- 5 years).\n\nWill have physiologic testing at baseline to assess thyroid function and fatigue assessment and management inventory. Will follow-up on management of therapy complications for thyroid disorder if one identified or until off study.", 'interventionNames': ['Other: physiologic testing', 'Procedure: fatigue assessment and management', 'Procedure: management of therapy complications']}], 'interventions': [{'name': 'physiologic testing', 'type': 'OTHER', 'otherNames': ['thyroid function tests'], 'description': 'Markers of thyroid function including thyroid stimulating hormone (TSH), Free thyroxine (free T4) and Thyroid peroxidase antibody (TPO Ab). These will be performed at baseline, in 12 months and again 24 months after enrollment. All thyroid function marker assays will be performed by LabCorp.', 'armGroupLabels': ['Group 1 Breast Cancer Patient Cases', 'Group 2 Healthy Controls']}, {'name': 'fatigue assessment and management', 'type': 'PROCEDURE', 'otherNames': ['FSI', 'Fatigue Symptoms Inventory'], 'description': 'Fatigue Symptoms Inventory (FSI) survey', 'armGroupLabels': ['Group 1 Breast Cancer Patient Cases', 'Group 2 Healthy Controls']}, {'name': 'management of therapy complications', 'type': 'PROCEDURE', 'description': 'If baseline testing results suggest hyperthyroidism or hypothyroidism, the enrolling center will give test results to participants for follow-up with their primary healthcare provider. Participants with hypothyroidism, who are not started on thyroid hormone, will continue on study, given the TSH level is below 10. Those with hypothyroidism who have treatment initiated will not continue on study. Participants who develop hypothyroidism during the study will not continue on-study if replacement therapy is initiated or if the TSH level is 10 or higher. Work up the next control nominated by the patient or contact the patient for the name of another control', 'armGroupLabels': ['Group 1 Breast Cancer Patient Cases', 'Group 2 Healthy Controls']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85006-2726', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'CCOP - Western Regional, Arizona', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '80631-5199', 'city': 'Greeley', 'state': 'Colorado', 'country': 'United States', 'facility': 'North Colorado Medical Center', 'geoPoint': {'lat': 40.42331, 'lon': -104.70913}}, {'zip': '80538', 'city': 'Loveland', 'state': 'Colorado', 'country': 'United States', 'facility': 'McKee Medical Center', 'geoPoint': {'lat': 40.39776, 'lon': -105.07498}}, {'zip': '34788', 'city': 'Leesburg', 'state': 'Florida', 'country': 'United States', 'facility': 'Cancer Centers of Central Florida, PA', 'geoPoint': {'lat': 28.81082, 'lon': -81.87786}}, {'zip': '33612-9497', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'H. Lee Moffitt Cancer Center and Research Institute at University of South Florida', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '30607', 'city': 'Athens', 'state': 'Georgia', 'country': 'United States', 'facility': 'Northeast Georgia Cancer Care, LLC - Medical Oncology', 'geoPoint': {'lat': 33.96095, 'lon': -83.37794}}, {'zip': '30912-3500', 'city': 'Augusta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Medical College of Georgia Cancer Center', 'geoPoint': {'lat': 33.47097, 'lon': -81.97484}}, {'zip': '30912-4000', 'city': 'Augusta', 'state': 'Georgia', 'country': 'United States', 'facility': 'MBCCOP - Medical College of Georgia Cancer Center', 'geoPoint': {'lat': 33.47097, 'lon': -81.97484}}, {'zip': '62002', 'city': 'Alton', 'state': 'Illinois', 'country': 'United States', 'facility': "Saint Anthony's Hospital at Saint Anthony's Health Center", 'geoPoint': {'lat': 38.8906, 'lon': -90.18428}}, {'zip': '62864', 'city': 'Mount Vernon', 'state': 'Illinois', 'country': 'United States', 'facility': 'Good Samaritan Regional Health Center', 'geoPoint': {'lat': 38.31727, 'lon': -88.90312}}, {'zip': '70112', 'city': 'New Orleans', 'state': 'Louisiana', 'country': 'United States', 'facility': 'MBCCOP - LSU Health Sciences Center', 'geoPoint': {'lat': 29.95465, 'lon': -90.07507}}, {'zip': '71130-3932', 'city': 'Shreveport', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Feist-Weiller Cancer Center at Louisiana State University Health Sciences', 'geoPoint': {'lat': 32.52515, 'lon': -93.75018}}, {'zip': '48073-6769', 'city': 'Royal Oak', 'state': 'Michigan', 'country': 'United States', 'facility': 'CCOP - Beaumont', 'geoPoint': {'lat': 42.48948, 'lon': -83.14465}}, {'zip': '48073', 'city': 'Royal Oak', 'state': 'Michigan', 'country': 'United States', 'facility': 'William Beaumont Hospital - Royal Oak Campus', 'geoPoint': {'lat': 42.48948, 'lon': -83.14465}}, {'zip': '48085', 'city': 'Troy', 'state': 'Michigan', 'country': 'United States', 'facility': 'William Beaumont Hospital - Troy Campus', 'geoPoint': {'lat': 42.60559, 'lon': -83.14993}}, {'zip': '56601', 'city': 'Bemidji', 'state': 'Minnesota', 'country': 'United States', 'facility': 'MeritCare Bemidji', 'geoPoint': {'lat': 47.47356, 'lon': -94.88028}}, {'zip': '63701', 'city': 'Cape Girardeau', 'state': 'Missouri', 'country': 'United States', 'facility': 'Southeast Cancer Center', 'geoPoint': {'lat': 37.30588, 'lon': -89.51815}}, {'zip': '63703', 'city': 'Cape Girardeau', 'state': 'Missouri', 'country': 'United States', 'facility': 'Saint Francis Medical Center', 'geoPoint': {'lat': 37.30588, 'lon': -89.51815}}, {'zip': '65804-2263', 'city': 'Springfield', 'state': 'Missouri', 'country': 'United States', 'facility': "St. John's Regional Health Center", 'geoPoint': {'lat': 37.21533, 'lon': -93.29824}}, {'zip': '65804', 'city': 'Springfield', 'state': 'Missouri', 'country': 'United States', 'facility': 'CCOP - Cancer Research for the Ozarks', 'geoPoint': {'lat': 37.21533, 'lon': -93.29824}}, {'zip': '65807', 'city': 'Springfield', 'state': 'Missouri', 'country': 'United States', 'facility': 'Hulston Cancer Center at Cox Medical Center South', 'geoPoint': {'lat': 37.21533, 'lon': -93.29824}}, {'zip': '63141', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'CCOP - St. Louis-Cape Girardeau', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '63141', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': "David C. Pratt Cancer Center at St. John's Mercy", 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '07112', 'city': 'Newark', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Newark Beth Israel Medical Center', 'geoPoint': {'lat': 40.73566, 'lon': -74.17237}}, {'zip': '10466', 'city': 'The Bronx', 'state': 'New York', 'country': 'United States', 'facility': 'MBCCOP - Our Lady of Mercy Comprehensive Cancer Center', 'geoPoint': {'lat': 40.84985, 'lon': -73.86641}}, {'zip': '10466', 'city': 'The Bronx', 'state': 'New York', 'country': 'United States', 'facility': 'Our Lady of Mercy Medical Center Comprehensive Cancer Center', 'geoPoint': {'lat': 40.84985, 'lon': -73.86641}}, {'zip': '28801', 'city': 'Asheville', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Mission Hospitals - Memorial Campus', 'geoPoint': {'lat': 35.60095, 'lon': -82.55402}}, {'zip': '28043', 'city': 'Forest City', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Rutherford Internal Medicine Associates, PA', 'geoPoint': {'lat': 35.33401, 'lon': -81.8651}}, {'zip': '27534-9479', 'city': 'Goldsboro', 'state': 'North Carolina', 'country': 'United States', 'facility': 'CCOP - Southeast Cancer Control Consortium', 'geoPoint': {'lat': 35.38488, 'lon': -77.99277}}, {'zip': '27534', 'city': 'Goldsboro', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Southeastern Medical Oncology Center - Goldsboro', 'geoPoint': {'lat': 35.38488, 'lon': -77.99277}}, {'zip': '27403-1198', 'city': 'Greensboro', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Moses Cone Regional Cancer Center at Wesley Long Community Hospital', 'geoPoint': {'lat': 36.07264, 'lon': -79.79198}}, {'zip': '28791', 'city': 'Hendersonville', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Pardee Memorial Hospital', 'geoPoint': {'lat': 35.31873, 'lon': -82.46095}}, {'zip': '28687-1828', 'city': 'Statesville', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Iredell Memorial Hospital', 'geoPoint': {'lat': 35.78264, 'lon': -80.8873}}, {'zip': '27893', 'city': 'Wilson', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Southeastern Medical Oncology Center - Wilson', 'geoPoint': {'lat': 35.72127, 'lon': -77.91554}}, {'zip': '27103', 'city': 'Winston-Salem', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Forsyth Regional Cancer Center at Forsyth Medical Center', 'geoPoint': {'lat': 36.09986, 'lon': -80.24422}}, {'zip': '58122', 'city': 'Fargo', 'state': 'North Dakota', 'country': 'United States', 'facility': 'CCOP - MeritCare Hospital', 'geoPoint': {'lat': 46.87719, 'lon': -96.7898}}, {'zip': '58122', 'city': 'Fargo', 'state': 'North Dakota', 'country': 'United States', 'facility': 'Roger Maris Cancer Center at MeritCare Hospital', 'geoPoint': {'lat': 46.87719, 'lon': -96.7898}}, {'zip': '29621', 'city': 'Anderson', 'state': 'South Carolina', 'country': 'United States', 'facility': 'AnMed Cancer Center', 'geoPoint': {'lat': 34.50344, 'lon': -82.65013}}, {'zip': '29303', 'city': 'Spartanburg', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Gibbs Regional Cancer Center at Spartanburg Regional Medical Center', 'geoPoint': {'lat': 34.94957, 'lon': -81.93205}}, {'zip': '76508', 'city': 'Temple', 'state': 'Texas', 'country': 'United States', 'facility': 'CCOP - Scott and White Hospital', 'geoPoint': {'lat': 31.09823, 'lon': -97.34278}}, {'zip': '76508', 'city': 'Temple', 'state': 'Texas', 'country': 'United States', 'facility': 'Scott and White Cancer Institute', 'geoPoint': {'lat': 31.09823, 'lon': -97.34278}}], 'overallOfficials': [{'name': 'Nagi B. Kumar, PhD RD FADA', 'role': 'STUDY_CHAIR', 'affiliation': 'H. Lee Moffitt Cancer Center and Research Institute'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of South Florida', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}