Ignite Creation Date:
2025-12-24 @ 11:25 PM
Ignite Modification Date:
2026-01-04 @ 4:58 PM
Study NCT ID:
NCT00460356
Status:
COMPLETED
Last Update Posted:
2017-08-24
First Post:
2007-04-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Glycoprotein and Glycan in Tissue and Blood Samples of Patients With Stage IB-IVA Cervical Cancer Undergoing Surgery to Remove Pelvic and Abdominal Lymph Nodes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002583', 'term': 'Uterine Cervical Neoplasms'}], 'ancestors': [{'id': 'D014594', 'term': 'Uterine Neoplasms'}, {'id': 'D005833', 'term': 'Genital Neoplasms, Female'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D002577', 'term': 'Uterine Cervical Diseases'}, {'id': 'D014591', 'term': 'Uterine Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008197', 'term': 'Lymph Node Excision'}], 'ancestors': [{'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'enrollmentInfo': {'type': 'ACTUAL', 'count': 159}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-04-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-08', 'completionDateStruct': {'date': '2016-07-16', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-08-23', 'studyFirstSubmitDate': '2007-04-11', 'studyFirstSubmitQcDate': '2007-04-11', 'lastUpdatePostDateStruct': {'date': '2017-08-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2007-04-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-07-16', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Differences in 10 of the 300 carbohydrates under examination using the customized glycan array', 'timeFrame': 'Up to 3 years'}, {'measure': 'Differences in approximately 50 of the 400 genes on the customized glycogene expression array', 'timeFrame': 'Up to 3 years'}, {'measure': 'Level of immunohistochemical staining for Tn antigen and sialyl Tn antigen', 'timeFrame': 'Up to 3 years'}, {'measure': 'Presence of T-synthase or Cosmc mutation', 'timeFrame': 'Up to 3 years'}], 'secondaryOutcomes': [{'measure': 'Local control', 'timeFrame': 'Up to 3 years'}, {'measure': 'Lymph node metastasis', 'timeFrame': 'Up to 3 years'}, {'measure': 'Overall survival', 'timeFrame': 'Up to 3 years'}, {'measure': 'Progression-free survival (recurrence and disease progression)', 'timeFrame': 'Up to 3 years'}]}, 'conditionsModule': {'conditions': ['Cervical Adenocarcinoma', 'Cervical Adenosquamous Carcinoma', 'Cervical Small Cell Carcinoma', 'Cervical Squamous Cell Carcinoma, Not Otherwise Specified', 'Stage IB Cervical Cancer', 'Stage IIA Cervical Cancer', 'Stage IIB Cervical Cancer', 'Stage III Cervical Cancer', 'Stage IVA Cervical Cancer']}, 'descriptionModule': {'briefSummary': 'This clinical trial studies glycoprotein and glycan in tissue and blood samples of patients with stage IB-IVA cervical cancer undergoing surgery to remove pelvic and abdominal lymph nodes. Studying samples of tumor tissue and blood from patients with cancer in the laboratory may help doctors learn more about changes that occur in deoxyribonucleic acid (DNA) and identify biomarkers related to cancer. It may also help doctors learn how far the disease has spread.', 'detailedDescription': 'PRIMARY OBJECTIVE:\n\nI. Determine whether the presence of a mutation in T-synthase or Cosmc and/or the presence of positive immunohistochemical expression of Tn antigen or sialyl Tn antigen in tumor specimens is associated with progression-free or overall survival in patients with stage IB2, II, III, or IVA cervical cancer undergoing pelvic and para-aortic (abdominal) lymphadenectomy.\n\nSECONDARY OBJECTIVES:\n\nI. Determine whether the presence of a mutation in T-synthase or Cosmc and/or the presence of positive immunohistochemical expression of Tn antigen or sialyl Tn antigen in tumor specimens is associated with lymph node metastasis or local control.\n\nII. Identify a glycoprotein profile from a customized gene expression array analysis in tumor specimens or a glycan profile from a customized glycan array in serum that is associated with lymph node metastasis, local control, disease recurrence/progression, or survival.\n\nIII. Determine whether differences exist in T-synthase or Cosmc mutations, the immunohistochemical expression of Tn antigen or sialyl Tn antigen, and glycoprotein profiling (using customized gene expression array analysis) in matched primary tumor compared with metastatic lymph nodes that are associated with lymph node metastasis, local control, disease recurrence/progression, or survival.\n\nIV. Identify differences in glycoprotein expression profiling and glycan profiling in tumor specimens with or without a mutation in T-synthase or Cosmc, or in tumor specimens with or without positive immunohistochemical expression of Tn antigen or sialyl Tn antigen that are associated with lymph node metastasis, local control, disease recurrence/progression, or survival.\n\nOUTLINE:\n\nPrimary and metastatic tumor specimens are collected during lymphadenectomy and used for tissue microarray analysis, mutational analysis of T-synthase and Cosmc, immunohistochemical staining of Tn antigen and sialyl Tn antigen, and customized gene expression array analysis of 400 genes associated with glycobiology. Pre-lymphadenectomy blood is collected from patients at baseline for customized glycan array analysis of 300 carbohydrates.\n\nAfter completion of study treatment, patients are followed up every 3 months for 2 years and then every 6 months for 3 years.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with primary, previously untreated, histologically confirmed locoregionally advanced (Stages IB2, IIA \\> 4 cm, IIB-IVA) invasive carcinoma of the cervix (any cell type) who will undergo pelvic and para-aortic (abdominal) lymphadenectomy to determine the presence or absence of lymph node metastasis\n* Patients who have met the pre-entry requirements\n* Patients with a block or 25 unstained sections of formalin-fixed and paraffin-embedded primary tumor available to satisfy the primary tumor requirement\n* Patients who have signed an approved informed consent and authorization permitting release of personal health information\n\nExclusion Criteria:\n\n* Patients who do not satisfy pre-entry requirements'}, 'identificationModule': {'nctId': 'NCT00460356', 'briefTitle': 'Glycoprotein and Glycan in Tissue and Blood Samples of Patients With Stage IB-IVA Cervical Cancer Undergoing Surgery to Remove Pelvic and Abdominal Lymph Nodes', 'organization': {'class': 'NETWORK', 'fullName': 'GOG Foundation'}, 'officialTitle': 'Glycoprotein and Glycan Profiling in Patients With Locally Advanced Cervical Cancer (Stage IB2, IIA > 4 CM, IIB to IVA) Undergoing Pelvic and Para-aortic (Abdominal) Lymphadenectomy', 'orgStudyIdInfo': {'id': 'GOG-0221'}, 'secondaryIdInfos': [{'id': 'NCI-2009-00592', 'type': 'REGISTRY', 'domain': 'CTRP (Clinical Trial Reporting Program)'}, {'id': 'CDR0000540243'}, {'id': 'GOG-0221', 'type': 'OTHER', 'domain': 'NRG Oncology'}, {'id': 'GOG-0221', 'type': 'OTHER', 'domain': 'CTEP'}, {'id': 'U10CA180868', 'link': 'https://reporter.nih.gov/quickSearch/U10CA180868', 'type': 'NIH'}, {'id': 'U10CA027469', 'link': 'https://reporter.nih.gov/quickSearch/U10CA027469', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Ancillary-Correlative (glycoprotein and glycan profiling)', 'description': 'Primary and metastatic tumor specimens are collected during lymphadenectomy and used for tissue microarray analysis, mutational analysis of T-synthase and Cosmc, immunohistochemical staining of Tn antigen and sialyl Tn antigen, and customized gene expression array analysis of 400 genes associated with glycobiology. Pre-lymphadenectomy blood is collected from patients at baseline for customized glycan array analysis of 300 carbohydrates.', 'interventionNames': ['Other: Laboratory Biomarker Analysis', 'Procedure: Lymphadenectomy']}], 'interventions': [{'name': 'Laboratory Biomarker Analysis', 'type': 'OTHER', 'description': 'Correlative studies', 'armGroupLabels': ['Ancillary-Correlative (glycoprotein and glycan profiling)']}, {'name': 'Lymphadenectomy', 'type': 'PROCEDURE', 'otherNames': ['excision of the lymph node', 'lymph node dissection', 'lymph node excision'], 'description': 'Undergo lymphadenectomy', 'armGroupLabels': ['Ancillary-Correlative (glycoprotein and glycan profiling)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92868', 'city': 'Orange', 'state': 'California', 'country': 'United States', 'facility': 'UC Irvine Health/Chao Family Comprehensive Cancer Center', 'geoPoint': {'lat': 33.78779, 'lon': -117.85311}}, {'zip': '91342', 'city': 'Sylmar', 'state': 'California', 'country': 'United States', 'facility': 'Olive View-University of California Los Angeles Medical Center', 'geoPoint': {'lat': 34.30778, 'lon': -118.44925}}, {'zip': '30912', 'city': 'Augusta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Augusta University Medical Center', 'geoPoint': {'lat': 33.47097, 'lon': -81.97484}}, {'zip': '48201', 'city': 'Detroit', 'state': 'Michigan', 'country': 'United States', 'facility': 'Wayne State University/Karmanos Cancer Institute', 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}, {'zip': '63110', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Saint Louis University Hospital', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '89109', 'city': 'Las Vegas', 'state': 'Nevada', 'country': 'United States', 'facility': 'Sunrise Hospital and Medical Center', 'geoPoint': {'lat': 36.17497, 'lon': -115.13722}}, {'zip': '89169', 'city': 'Las Vegas', 'state': 'Nevada', 'country': 'United States', 'facility': "Women's Cancer Center of Nevada", 'geoPoint': {'lat': 36.17497, 'lon': -115.13722}}, {'zip': '10461', 'city': 'The Bronx', 'state': 'New York', 'country': 'United States', 'facility': 'Montefiore Medical Center-Einstein Campus', 'geoPoint': {'lat': 40.84985, 'lon': -73.86641}}, {'zip': '44304', 'city': 'Akron', 'state': 'Ohio', 'country': 'United States', 'facility': 'Summa Akron City Hospital/Cooper Cancer Center', 'geoPoint': {'lat': 41.08144, 'lon': -81.51901}}, {'zip': '45219', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'University of Cincinnati/Barrett Cancer Center', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '44106', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'Case Western Reserve University', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '44111', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'Cleveland Clinic Cancer Center/Fairview Hospital', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '44195', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'Cleveland Clinic Foundation', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '44124', 'city': 'Mayfield Heights', 'state': 'Ohio', 'country': 'United States', 'facility': 'Hillcrest Hospital Cancer Center', 'geoPoint': {'lat': 41.51922, 'lon': -81.4579}}, {'zip': '44060', 'city': 'Mentor', 'state': 'Ohio', 'country': 'United States', 'facility': 'Lake University Ireland Cancer Center', 'geoPoint': {'lat': 41.66616, 'lon': -81.33955}}, {'zip': '73104', 'city': 'Oklahoma City', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'University of Oklahoma Health Sciences Center', 'geoPoint': {'lat': 35.46756, 'lon': -97.51643}}, {'zip': '74146', 'city': 'Tulsa', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'Oklahoma Cancer Specialists and Research Institute-Tulsa', 'geoPoint': {'lat': 36.15398, 'lon': -95.99277}}, {'zip': '02905', 'city': 'Providence', 'state': 'Rhode Island', 'country': 'United States', 'facility': 'Women and Infants Hospital', 'geoPoint': {'lat': 41.82399, 'lon': -71.41283}}], 'overallOfficials': [{'name': 'Michael Gold', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'NRG Oncology'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Gynecologic Oncology Group', 'class': 'NETWORK'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}