A Predictive Model for Early Metastasis in Cervical Cancer Patients After Radiotherapy
Sponsor
Fujian Cancer Hospital (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06101966
Collaborator
(none)
500
1
48
10.4
Study Details
Study Description
Brief Summary
This study aims to help to screen out appropriate cases for consolidation therapy and more intensive follow up.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Detailed Description
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
Study Design
Study Type:
Observational
Anticipated Enrollment
:
500 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
A Novel Predictive Model and Risk Stratification for Early Metastasis in Cervical Cancer Patients After Radiotherapy
Anticipated Study Start Date
:
Dec 1, 2023
Anticipated Primary Completion Date
:
Dec 1, 2027
Anticipated Study Completion Date
:
Dec 1, 2027
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| cervical cancer patients with radiotherapy The overall dose should be more than 75 Gy. patients received surgery should be excluded. |
Radiation: external pelvic beam radiotherapy (EBRT) followed by individualized high-dose-rate intracavitary brachytherapy (HDR-ICBT)
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.
|
Outcome Measures
Primary Outcome Measures
- Early distant metastases [3-12months]
Early distant metastasis defines as metastasis occurrence between 3 -12 months after radiotherapy.
Eligibility Criteria
Criteria
Ages Eligible for Study:
20 Years
to 85 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
Inclusion Criteria:
- patients confirmed as cervical cancer by biopsies and treated with radiotherapy were initially enrolled
Exclusion Criteria:
- (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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Fujian Cancer Hospital | Fuzhou | Fujian | China | 350014 |
Sponsors and Collaborators
- Fujian Cancer Hospital
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Fujian Cancer Hospital
ClinicalTrials.gov Identifier:
NCT06101966
Other Study ID Numbers:
- prof.Sun
First Posted:
Oct 26, 2023
Last Update Posted:
Oct 26, 2023
Last Verified:
Oct 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms: