Ignite Creation Date:
2025-12-24 @ 1:21 PM
Ignite Modification Date:
2026-02-22 @ 5:27 PM
Study NCT ID:
NCT06429995
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-05-28
First Post:
2023-09-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Standard Follow-up Program (SFP) for Breast Cancer Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011878', 'term': 'Radiotherapy'}, {'id': 'D059248', 'term': 'Chemoradiotherapy'}], 'ancestors': [{'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D003131', 'term': 'Combined Modality Therapy'}, {'id': 'D004358', 'term': 'Drug Therapy'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 10000}, 'targetDuration': '30 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2008-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2030-01-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-05-22', 'studyFirstSubmitDate': '2023-09-22', 'studyFirstSubmitQcDate': '2024-05-22', 'lastUpdatePostDateStruct': {'date': '2024-05-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-05-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2030-01-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Hemoglobin (Hb)', 'timeFrame': 'Before start of radiation therapy', 'description': 'Hb level (mmol/l) measured in blood'}, {'measure': 'Hematocrit (Ht)', 'timeFrame': 'Before start of radiation therapy', 'description': 'Ht levels (L/L) measured in blood'}, {'measure': 'Leukocytes', 'timeFrame': 'Before start of radiation therapy', 'description': 'Leukocytes + differential count (10E9/l) measured in blood'}, {'measure': 'Creatinine', 'timeFrame': 'Before start of radiation therapy', 'description': 'Creatinine levels (mmol/l) measured in blood'}, {'measure': 'Estimated Glomerular filtration rate (eGFR)', 'timeFrame': 'Before start of radiation therapy', 'description': 'eGFR calculated from creatinine levels (ml/min)'}, {'measure': 'Urea', 'timeFrame': 'Before start of radiation therapy', 'description': 'Urea levels (mmol/l) measured in blood'}, {'measure': 'Hemoglobin A1c (HbA1c)', 'timeFrame': 'Before start of radiation therapy', 'description': 'HbA1c levels (mmol/mol) measured in blood'}, {'measure': 'Cholesterol', 'timeFrame': 'Before start of radiation therapy', 'description': 'Cholesterol levels (mmol/L) measured in blood'}, {'measure': 'High-densitiy-lipoprotein cholesterol (HDL cholesterol)', 'timeFrame': 'Before start of radiation therapy', 'description': 'HDL cholesterol levels (mmol/L) measured in blood'}, {'measure': 'Low-density-lipoprotein cholesterol (LDL cholesterol)', 'timeFrame': 'Before start of radiation therapy', 'description': 'LDL cholesterol levels (mmol/L) measured in blood'}, {'measure': 'Triglycerides', 'timeFrame': 'Before start of radiation therapy', 'description': 'Triglycerides levels (mmol/L) measured in blood'}, {'measure': 'High sensitive C-reactive protein (hsCRP)', 'timeFrame': 'Before start of radiation therapy', 'description': 'HsCRP levels (mg/L) measured in blood'}, {'measure': 'Thyroid stimulating hormone (TSH)', 'timeFrame': 'Before start of radiation therapy, 1 and 2 years after radiation therapy', 'description': 'TSH levels (mU/L) measured in blood'}, {'measure': 'Free Thyroxine-4 (FT4)', 'timeFrame': 'Before start of radiation therapy, 1 and 2 years after radiation therapy', 'description': 'FT4 levels (pmol/L) measured in blood'}, {'measure': 'Patient-rated Demographics measured with the baseline questionnaire on Demographics', 'timeFrame': 'Before start of radiation therapy', 'description': 'Patient-rated demographics measured with the baseline questionnaire on Demographics (unvalidated questionnaire)'}, {'measure': 'Patient-rated symptoms measured with the EORTC QLQ-BR23', 'timeFrame': 'Before start of radiation therapy, at 2 weeks after last day of radiation therapy, and at 3,6,12 months after last day of radiation therapy and thereafter yearly, anticipated average 20 years', 'description': 'Patient-rated symptoms are measured with the Quality of Life Questionnaire-BR23 (EORTC QLQ-BR23)'}, {'measure': 'Patient-rated symptoms measured with the BCSCQ', 'timeFrame': 'Before start of radiation therapy, at 2 weeks after last day of radiation therapy, and at 3,6,12 months after last day of radiation therapy and thereafter yearly, anticipated average 20 years.', 'description': "Patient-rated symptoms are measured with the Breast Cancer Questionnaire (BCSCQ: Based on the BCTOS (1) and the questionnaire on Patients' satisfaction with the cosmetic outcome by Sneeuw at al.(2))"}, {'measure': 'Patient-rated symptoms measured with the questionnaire on Cardiovascular Diseases and Risk Factors and Lung Diseases (baseline)', 'timeFrame': 'Before start of radiation therapy', 'description': 'Patient-rated symptoms are measured with the baseline questionnaire on Cardiovascular Diseases and Risk Factors and Lung Diseases before start of radiation therapy (unvalidated questionnaire)'}, {'measure': 'Patient-rated symptoms with the questionnaire on Cardiovascular Diseases and Risk Factors and Lung Diseases (follow up)', 'timeFrame': '6 and 12 months after last day of radiation therapy and thereafter yearly, anticipated average 20 years', 'description': 'Patient-rated symptoms are measured with the follow up questionnaire on Cardiovascular Diseases and Risk Factors and Lung Diseases (semi)annually after last day of radiation therapy (unvalidated questionnaire)'}, {'measure': 'Patient-rated symptoms measured with the questionnaire on Performance Status', 'timeFrame': 'Before start of radiation therapy, at 2 weeks after last day of radiation therapy, and at 3,6,12 months after last day of radiation therapy and thereafter yearly, anticipated average 20 years', 'description': 'Patient-rated symptoms are measured with the questionnaire on Performance Status (unvalidated questionnaire)'}, {'measure': ': Patient-rated symptoms measured with the questionnaire on Locoregional Tumor Control/New Primary Tumor', 'timeFrame': '6 and 12 months after last day of radiation therapy and thereafter yearly, anticipated average 20 years', 'description': 'Patient-rated symptoms are measured with the questionnaire on Locoregional Tumor Control/New Primary Tumor (unvalidated questionnaire)'}, {'measure': 'Patient-rated Quality of Life measured with the EORTC QLQ-C30', 'timeFrame': 'Before start of radiation therapy, at 2 weeks after last day of radiation therapy, and at 3,6,12 months after last day of radiation therapy and thereafter yearly, anticipated average 20 years', 'description': 'Patient-rated quality of life is measured with the Quality-of-Life Questionnaire-C30 (EORTC QLQ-C30)'}, {'measure': 'Patient-rated Quality of Life measured with the EuroQoL-5D_5L', 'timeFrame': 'Before start of radiation therapy, at 2 weeks after last day of radiation therapy, and at 3,6,12 months after last day of radiation therapy and thereafter yearly, anticipated average 20 years', 'description': 'Patient-rated quality of life is measured with the EuroQol Health questionnaire 5-level version (EuroQoL-5D\\_5L)'}, {'measure': 'Patient-rated Quality of Life measured with EORTC QLQ-BR23', 'timeFrame': 'Before start of radiation therapy, at 2 weeks after last day of radiation therapy, and at 3,6,12 months after last day of radiation therapy and thereafter yearly, anticipated average 20 years', 'description': 'Patient-rated quality of life is measured with the Quality of Life Questionnaire-BR23 (EORTC QLQ-BR23).'}], 'primaryOutcomes': [{'measure': 'Score of Acute toxicity', 'timeFrame': 'Before start of radiation therapy and during radiation therapy and at 2 weeks after last day of radiation therapy.', 'description': 'Acute Toxicity is measured with Common Terminology Criteria for Adverse Events (CTCAE).'}, {'measure': 'Score of Late toxicity', 'timeFrame': 'At one and two years after last day of radiation therapy.', 'description': 'Late Toxicity is measured with Common Terminology Criteria for Adverse Events (CTCAE).'}], 'secondaryOutcomes': [{'measure': 'Overall survival', 'timeFrame': 'At 2 weeks after last day of radiation therapy and thereafter yearly, anticipated average 5-10 years.', 'description': 'Overall survival'}, {'measure': 'Loco-regional tumor control', 'timeFrame': 'At 2 weeks after last day of radiation therapy and thereafter yearly, anticipated average 5-10 years.', 'description': 'Loco-regional tumor control'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Acute toxicity', 'Late toxicity', 'Prediction models'], 'conditions': ['Breast Cancer']}, 'referencesModule': {'references': [{'pmid': '11413515', 'type': 'BACKGROUND', 'citation': 'Stanton AL, Krishnan L, Collins CA. Form or function? Part 1. Subjective cosmetic and functional correlates of quality of life in women treated with breast-conserving surgical procedures and radiotherapy. Cancer. 2001 Jun 15;91(12):2273-81.'}, {'pmid': '1470691', 'type': 'BACKGROUND', 'citation': "Sneeuw KC, Aaronson NK, Yarnold JR, Broderick M, Regan J, Ross G, Goddard A. Cosmetic and functional outcomes of breast conserving treatment for early stage breast cancer. 1. Comparison of patients' ratings, observers' ratings, and objective assessments. Radiother Oncol. 1992 Nov;25(3):153-9. doi: 10.1016/0167-8140(92)90261-r."}]}, 'descriptionModule': {'briefSummary': 'Motive:\n\nIn order to improve the treatment technique, a comprehensive follow-up program is needed to obtain all relevant patient, treatment and toxicity data from breast cancer patients.\n\nGoal:to set-up and maintain a database containing treatment results in terms of tumor control, side effects, complications and patient-reported quality of life.\n\nA standard database of patiënts receiving photon treatment will be created. These data are then linked to dose-volume data of radiotherapy, with the aim to build prediction models for both tumor control and toxicity after radio (chemo) therapy that can later be used for selecting patients for proton treatment.\n\nTo set-up and maintain a database containing treatment results in terms of tumor control, side effects, complications and patient-reported quality of life.\n\nA standard database of patients receiving photon treatment will be created. These data are then linked to dose-volume data of radiotherapy, with the aim to build prediction models for both tumor control and toxicity after radio (chemo) therapy that can later be used for selecting patients for proton treatment.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'genderBased': True, 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with breast cancer receiving radiotherapy', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with breast cancer Patients receiving a radiotherapy dose\n\nExclusion Criteria:\n\n* Failure to comply with any of the inclusion criteria'}, 'identificationModule': {'nctId': 'NCT06429995', 'acronym': 'SFPMAMMA', 'briefTitle': 'Standard Follow-up Program (SFP) for Breast Cancer Patients', 'organization': {'class': 'OTHER', 'fullName': 'University Medical Center Groningen'}, 'officialTitle': 'Standard Follow-up Program (SFP) for Breast Cancer Patients', 'orgStudyIdInfo': {'id': 'SFP MAMMA'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Radiotherapy', 'type': 'RADIATION', 'otherNames': ['chemoradiation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '9700RB', 'city': 'Groningen', 'country': 'Netherlands', 'facility': 'University Medical Center Groningen', 'geoPoint': {'lat': 53.21917, 'lon': 6.56667}}], 'overallOfficials': [{'name': 'Anne Crijns, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Medical Center Groningen'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Medical Center Groningen', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}