Ignite Creation Date:
2025-12-24 @ 4:03 PM
Ignite Modification Date:
2025-12-27 @ 8:08 PM
Study NCT ID:
NCT06101966
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-10-26
First Post:
2023-10-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Predictive Model for Early Metastasis in Cervical Cancer Patients After Radiotherapy
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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 500}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2023-12-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-10', 'completionDateStruct': {'date': '2027-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-10-21', 'studyFirstSubmitDate': '2023-10-21', 'studyFirstSubmitQcDate': '2023-10-21', 'lastUpdatePostDateStruct': {'date': '2023-10-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-10-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Early distant metastases', 'timeFrame': '3-12months', 'description': 'Early distant metastasis defines as metastasis occurrence between 3 -12 months after radiotherapy.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cervical Cancer', 'Radiotherapy', 'Distant Metastasis', 'Prognostic Model', 'Risk Factor']}, 'referencesModule': {'references': [{'pmid': '28816403', 'type': 'RESULT', 'citation': 'Okazawa-Sakai M, Mabuchi S, Isohashi F, Kawashima A, Yokoi E, Ogawa K, Kimura T. Predictors of distant relapse in patients with FIGO stage IIB-IVA cervical cancer treated with definitive radiotherapy. J Obstet Gynaecol Res. 2017 Nov;43(11):1743-1750. doi: 10.1111/jog.13446. Epub 2017 Aug 17.'}, {'pmid': '31417641', 'type': 'RESULT', 'citation': 'Liu X, Meng Q, Wang W, Zhou Z, Zhang F, Hu K. Predictors of Distant Metastasis in Patients with Cervical Cancer Treated with Definitive Radiotherapy. J Cancer. 2019 Jul 5;10(17):3967-3974. doi: 10.7150/jca.31538. eCollection 2019.'}, {'pmid': '27171673', 'type': 'RESULT', 'citation': 'Li H, Wu X, Cheng X. Advances in diagnosis and treatment of metastatic cervical cancer. J Gynecol Oncol. 2016 Jul;27(4):e43. doi: 10.3802/jgo.2016.27.e43.'}, {'pmid': '35410987', 'type': 'RESULT', 'citation': 'Zeng W, Huang L, Lin H, Pan R, Liu H, Wen J, Liang Y, Yang H. Development and Validation of a Nomogram for Predicting Postoperative Distant Metastasis in Patients with Cervical Cancer. Med Sci Monit. 2022 Apr 12;28:e933379. doi: 10.12659/MSM.933379.'}]}, 'descriptionModule': {'briefSummary': 'This study aims to help to screen out appropriate cases for consolidation therapy and more intensive follow up.', 'detailedDescription': 'Some cervical cancer patients experienced distant metastasis quickly after receiving complete radiotherapy and have a worse prognosis. However, there were few studies focused on these patients and with early distant metastasis. It is significant to predictive and screen out cervial cancer patients with a high risk of early metastasis for more comprehensive treatments and follow-up plans'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '20 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'cervical cancer patients recevied definitive radiotherapy.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients confirmed as cervical cancer by biopsies and treated with radiotherapy were initially enrolled\n\nExclusion Criteria:\n\n* (1) patients treated with surgery. (2) patient received incomplete treatment somewhere else. (3) patients with cancer history. (4) patients with pelvic surgery history. (5) patients without complete pre-treatment medical information. (6) patients with unfinished radical radiotherapy. (7) patients suffered from metastasis within 3 months after radiotherapy. (8) patients without complete 1-year follow-up materials'}, 'identificationModule': {'nctId': 'NCT06101966', 'briefTitle': 'A Predictive Model for Early Metastasis in Cervical Cancer Patients After Radiotherapy', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Fujian Cancer Hospital'}, 'officialTitle': 'A Novel Predictive Model and Risk Stratification for Early Metastasis in Cervical Cancer Patients After Radiotherapy', 'orgStudyIdInfo': {'id': 'prof.Sun'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'cervical cancer patients with radiotherapy', 'description': 'The overall dose should be more than 75 Gy. patients received surgery should be excluded.', 'interventionNames': ['Radiation: external pelvic beam radiotherapy (EBRT) followed by individualized high-dose-rate intracavitary brachytherapy (HDR-ICBT)']}], 'interventions': [{'name': 'external pelvic beam radiotherapy (EBRT) followed by individualized high-dose-rate intracavitary brachytherapy (HDR-ICBT)', 'type': 'RADIATION', 'description': "Radical RT consisted of external pelvic beam radiotherapy (EBRT) and individualized high-dose-rate intracavitary brachytherapy (HDR-ICBT).Cisplatin-based concurrent chemoradiotherapy (CCRT) was recommended for CC patients unless for economic status, age consideration and patients' desires.", 'armGroupLabels': ['cervical cancer patients with radiotherapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '350014', 'city': 'Fuzhou', 'state': 'Fujian', 'country': 'China', 'facility': 'Fujian Cancer Hospital', 'geoPoint': {'lat': 26.06139, 'lon': 119.30611}}], 'centralContacts': [{'name': 'Yang Sun, PhD', 'role': 'CONTACT', 'email': 'sunyang@fjzlhospital.com', 'phone': '+8615959028989'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fujian Cancer Hospital', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}