Ignite Creation Date:
2025-12-24 @ 11:54 PM
Ignite Modification Date:
2025-12-25 @ 9:49 PM
Study NCT ID:
NCT06781151
Status:
RECRUITING
Last Update Posted:
2025-08-27
First Post:
2025-01-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study to Explore Personalized Treatment for Patients With Recurrent Gynecological Malignancies Based on MTB
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010051', 'term': 'Ovarian Neoplasms'}, {'id': 'D016889', 'term': 'Endometrial Neoplasms'}, {'id': 'D002583', 'term': 'Uterine Cervical Neoplasms'}], 'ancestors': [{'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D010049', 'term': 'Ovarian Diseases'}, {'id': 'D000291', 'term': 'Adnexal 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': 'D005833', 'term': 'Genital Neoplasms, Female'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D006058', 'term': 'Gonadal Disorders'}, {'id': 'D014594', 'term': 'Uterine Neoplasms'}, {'id': 'D014591', 'term': 'Uterine Diseases'}, {'id': 'D002577', 'term': 'Uterine Cervical Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}, 'targetDuration': '2 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-04-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2027-06-18', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-20', 'studyFirstSubmitDate': '2025-01-05', 'studyFirstSubmitQcDate': '2025-01-13', 'lastUpdatePostDateStruct': {'date': '2025-08-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-01-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12-18', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'the overall response rate', 'timeFrame': 'an assessment was performed at the end of Cycle 2 or Cycle 3 or Cycle 4 (each cycle is 21-28 days) according to the actual situation', 'description': 'the overall response rate (ORR) by the presence of radiologically assessable disease by cross-sectional CT or MRI imaging and/or by MIBG or PET scans'}], 'secondaryOutcomes': [{'measure': 'the progression free survival (PFS)', 'timeFrame': '2 years', 'description': 'the time from the start of treatment until the disease progresses or the patient dies from any cause, whichever comes first.'}, {'measure': 'the overall survival (OS)', 'timeFrame': '2 years', 'description': 'a measure of the length of time from the start of treatment until death from any cause'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['genomic sequencing', 'molecular tumor boards', 'recurrent ovarian cancer', 'recurrent endometrial cancer', 'recurrent cervical cancer'], 'conditions': ['Ovarian Cancer Recurrent', 'Endometrial Cancer Recurrent', 'Cervical Cancer Recurrent']}, 'descriptionModule': {'briefSummary': 'This is a non-interventional, real-world study divided into two parts: a retrospective study and a prospective study.\n\nThe main question it aims to answer is:\n\nWill genomic sequencing and molecular tumor boards lead to clinical responses in patients with recurrent ovarian, cervical, or endometrial cancer? The retrospective arm will analyze data from patients with recurrent gynecological malignancies (ovarian, cervical, or endometrial) who underwent multidisciplinary consultations at our institution from January 2022 onward. Data collected will include tumor tissue genomic sequencing results, medical histories, multidisciplinary consultation recommendations, and subsequent treatment courses. This analysis will examine the implementation and clinical efficacy of personalized targeted therapies guided by molecular tumor profiling and multidisciplinary consultation.\n\nThe prospective arm will enroll 200 patients with recurrent gynecological malignancies (ovarian, cervical, or endometrial) referred for multidisciplinary consultation. Tumor tissue and blood samples will undergo next-generation sequencing (NGS) to determine molecular tumor profiles. A multidisciplinary expert panel will formulate individualized treatment strategies based on these profiles, patient clinical data, and treatment history. Attending physicians will determine the final treatment plan, integrating multidisciplinary recommendations with patient preferences, comorbidity considerations, drug toxicity assessments, insurance coverage for off-label medications, and the availability of investigational drug trials. This arm aims to observe and evaluate the clinical efficacy of personalized treatment plans developed through molecular tumor profiling and multidisciplinary consultation.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with recurrent ovarian, cervical, or endometrial cancer referred for multidisciplinary consultation by a gynecological oncologist', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with recurrent ovarian, cervical, or endometrial cancer referred for multidisciplinary consultation by a gynecological oncologist;\n* Presence of at least one evaluable lesion;\n* Willingness to participate in multidisciplinary consultation;\n* Age 18 years or older;\n* Sufficient tumor tissue for next-generation sequencing (NGS) with a tumor content greater than 32%;\n* Informed consent provided by the participant, indicating understanding of the study procedures and willingness to participate.\n\nExclusion Criteria:\n\n* Patients with concurrent malignancies;\n* Pregnant patients.'}, 'identificationModule': {'nctId': 'NCT06781151', 'acronym': 'RWS-MTB', 'briefTitle': 'A Study to Explore Personalized Treatment for Patients With Recurrent Gynecological Malignancies Based on MTB', 'organization': {'class': 'OTHER', 'fullName': 'Sun Yat-sen University'}, 'officialTitle': 'A Real-world Study to Explore Personalized Treatment for Patients With Recurrent Gynecological Malignancies Based on Molecular Profiling and Multidisciplinary Team Consultation', 'orgStudyIdInfo': {'id': '2023-FXY-274'}}, 'contactsLocationsModule': {'locations': [{'zip': '510000', 'city': 'Guangzhou', 'state': 'Guangdong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xiaolin Luo, phD', 'role': 'CONTACT', 'email': 'luoxl@sysucc.org.cn', 'phone': '15017599965'}], 'facility': "Sun Yat'sen University Cancer Center", 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'zip': '518000', 'city': 'Shenzhen', 'state': 'Guangdong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Jingjing Wang', 'role': 'CONTACT'}], 'facility': 'Cancer Hospital Chinese Academy of Medical Sciences,Shenzhen Center', 'geoPoint': {'lat': 22.54554, 'lon': 114.0683}}], 'centralContacts': [{'name': 'Xiaolin Luo, PhD', 'role': 'CONTACT', 'email': 'luoxl@sysucc.org.cn', 'phone': '15017599965'}], 'overallOfficials': [{'name': 'Jihong Liu, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Sun Yat'sen University Cancer Center"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sun Yat-sen University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Cancer Hospital Chinese Academy of Medical Science, Shenzhen Center', 'class': 'OTHER'}, {'name': 'Obstetrics & Gynecology Hospital of Fudan University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'professor', 'investigatorFullName': 'Jihong Liu', 'investigatorAffiliation': 'Sun Yat-sen University'}}}}