Ignite Creation Date:
2025-12-25 @ 4:54 AM
Ignite Modification Date:
2025-12-26 @ 3:55 AM
Study NCT ID:
NCT03420118
Status:
RECRUITING
Last Update Posted:
2025-12-05
First Post:
2017-11-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study of Biomarkers in Gynecological Cancers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D001800', 'term': 'Blood Specimen Collection'}], 'ancestors': [{'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D011677', 'term': 'Punctures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1000}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-12-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2027-12-21', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-03', 'studyFirstSubmitDate': '2017-11-16', 'studyFirstSubmitQcDate': '2018-01-26', 'lastUpdatePostDateStruct': {'date': '2025-12-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2018-02-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12-21', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Genomic and immune signatures in terms of progression free survival', 'timeFrame': '5 years'}, {'measure': 'Genomic and immune signatures in terms of overall survival', 'timeFrame': '5 years'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Gynecologic Cancer']}, 'descriptionModule': {'briefSummary': 'In recent years, there has been a significant improvement in understanding the biology of cancer and this information has been used to improve cancer care and patient outcome.\n\nResearch has shown that changes in some genes and/or proteins may be important indicators for certain cancers and response to treatments. Genes are molecules made up of ribonucleic acid (RNA) and deoxyribonucleic acid (DNA). DNA contain instructions for the development and functioning of the cells in the body and are passed down from parent to child. RNA is involved with producing proteins in the body. Further research is needed to better understand the changes found in cancer cells and how to target them to stop or reduce cancer growth.\n\nA drug that may be able to block certain specific cancer cell changes is called "targeted therapy". Different people with the same type of cancer receiving the same drug could have different responses to it. For example, one person may experience a reduction of their tumor while another person\'s cancer may worsen. The reason for this is still not well understood and could lie in gene changes.\n\nUnderstanding these changes may allow researchers to predict how treatments may work in guiding decisions around choice of drugs.\n\nThe purpose of the study is to learn more about gene changes or protein expression (levels) of tumors to better understand the behavior of gynecological diseases and, if possible, better address participants\' cancer care now or in the future.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Pre-Screening Eligibility:\n\nInclusion Criteria:\n\n* Patients with probable diagnoses of gynecological malignancy (ovarian, tubal, primary peritoneal, uterine, cervical, vulvar and rare gynecological cancers) and confirmed to be undergoing upfront debulking surgery/radiation\n* Patient must be ≥16 years of age at the time of consent.\n* Ability to understand and provide written informed consent.\n* ECOG Performance Status ≤ 2.\n* Patient must consent to provide tissue sample from surgery and blood samples\n* Life expectancy ≥3 months.\n\nExclusion Criteria:\n\n* Patients must be treatment naïve (no previous treatment of Neoadjuvant chemotherapy nor radiation for newly diagnosed disease)\n\nEligibility for Patients with Gynecological Diagnosis\n\nInclusion Criteria:\n\n* Patients with histological confirmation of gynecological malignancy (except ovarian cancer with high grade serous histology, tubal, primary peritoneal, uterine, cervical, vulvar and vaginal cancer and rare gynecological cancers).\n* Patient must be ≥16 years of age at the time of consent.\n* Ability to understand and provide written informed consent.\n* Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 2.\n* Patient must consent to providing archival tissue and/or to undergo tumour biopsy and/or to provide blood or fluid collection samples. Patients will also be asked to provide a blood sample for germline mutation analysis.\n* Life expectancy ≥3 months.\n* No limits of previous lines of treatment.\n\nExclusion Criteria:\n\n* Any contraindication to tumour biopsy or blood collection\n* Patient with diagnosis of High grade serous Ovarian Cancer are excluded'}, 'identificationModule': {'nctId': 'NCT03420118', 'acronym': 'VENUS', 'briefTitle': 'Study of Biomarkers in Gynecological Cancers', 'organization': {'class': 'OTHER', 'fullName': 'University Health Network, Toronto'}, 'officialTitle': 'Molecular and Immunological Characterization of Gynecological Malignancies', 'orgStudyIdInfo': {'id': 'VENUS'}, 'secondaryIdInfos': [{'id': '17-5411', 'type': 'OTHER', 'domain': 'UHN REB'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Tumor tissue and blood samples collection', 'interventionNames': ['Procedure: Tumour tissue collection', 'Procedure: Blood draws']}], 'interventions': [{'name': 'Tumour tissue collection', 'type': 'PROCEDURE', 'description': "Depending on the status of disease when participants join the study, a sample of tumour tissue may be collected from:\n\n* A previous surgery for the disease,\n* A biopsy for diagnosing the disease,\n* Other surgical procedures done for clinical management or possible cancer related complications (e.g., bowel obstruction).\n\nIn addition:\n\n* Patients undergoing pre-screening prior to diagnosis will have tumour sample collected at the time of surgery.\n* At anytime participants require a biopsy as a part of their cancer care, a sample of that tumour tissue will be collected.\n* New biopsies will be done to collect fresh tumour tissue each time participants' disease worsens.", 'armGroupLabels': ['Tumor tissue and blood samples collection']}, {'name': 'Blood draws', 'type': 'PROCEDURE', 'description': 'Blood samples will be collected at the following different times points:\n\n* All patient undergoing pre-screening for histological diagnosis will have blood samples collected.\n* Before starting a new line of treatment for the disease,\n* One week after starting a new line of treatment for the disease,\n* During treatment, at each radiological assessment (imaging scan) that will be done to check the status of the disease,\n* At the time the disease worsens or relapses (comes back)\n* During observation/follow-up, at the time of any radiological assessments that will be done to check the status of the disease', 'armGroupLabels': ['Tumor tissue and blood samples collection']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'M5G 1Z5', 'city': 'Toronto', 'state': 'Ontario', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Amit Oza, M.D.', 'role': 'CONTACT', 'email': 'amit.oza@uhn.ca', 'phone': '416-946-2818'}], 'facility': 'Princess Margaret Cancer Centre', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}], 'centralContacts': [{'name': 'Amit Oza, M.D.', 'role': 'CONTACT', 'email': 'amit.oza@uhn.ca', 'phone': '416-946-2818'}], 'overallOfficials': [{'name': 'Amit Oza, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Princess Margaret Cancer Centre'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Health Network, Toronto', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}