A Prospective, Multi-center, Real-world Study of Ovarian Metastatic Colorectal Cancer Patients
proOMCRC
Impact of Different Treatment Strategies on the Prognosis of Ovarian Metastatic Colorectal Cancer Patients: a Prospective, Multi-center, Real-world Study
1 other identifier
observational
400
1 country
4
Brief Summary
This prospective, multi-center, real-world study is conducted to investigate the impact of different treatment strategies (systemic chemotherapy combined with oophorectomy or with other local treatment or chemotherapy alone) on the prognosis of ovarian metastatic colorectal cancer patients.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2021
Longer than P75 for all trials
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 14, 2021
CompletedFirst Submitted
Initial submission to the registry
January 15, 2021
CompletedFirst Posted
Study publicly available on registry
January 20, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 14, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
September 14, 2025
CompletedAugust 6, 2024
August 1, 2024
4.7 years
January 15, 2021
August 3, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Ovarian specific overall survival
Calculated from the date of diagnosis with ovarian metastasis to death (caused by cancer) or last follow-up time.
up to 3 years
Secondary Outcomes (4)
Ovarian specific objective response rate
6 months
Extra-ovarian specific objective response rate
6 months
Progression free survival
6 months
Quality of life questionnaire
6 months
Eligibility Criteria
Patients diagnosed with ovarian metastatic colorectal cancer.
You may qualify if:
- Histologically confirmed colorectal adenocarcinoma;
- Histologically or radiologically diagnosed with ovarian metastasis, whether or not combined with metastases in other organs;
- Women ≥18 years of age;
- Eastern Cooperative Oncology Group performance status score ≤2;
- Available imaging data if the disease is measurable according to RECIST criteria version 1.1; patients are eligible if there is no measurable lesion.
- Complete medical records;
- Informed consent form signed.
You may not qualify if:
- Not ovarian metastatic colorectal cancer confirmed by radiology or histology;
- Drug abuse or other medical, psychological and social disorders that would interfere with cooperation with the requirements of the study;
- Other conditions that would influence patient compliance;
- Pregnant or breastfeeding female; male and female unwilling to take any contraceptive measures.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 510060, China
Cancer Hospital of China Medical University, Liaoning Cancer Hospital & Institute
Shenyang, Liaoning, 110042, China
West China Hospital of Sichuan University
Chengdu, Sichuan, 610041, China
Changhai Hospital, Naval Medical University
Shanghai, 200433, China
Biospecimen
samples of ovarian metastases if available
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Target Duration
- 3 Years
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Prof.
Study Record Dates
First Submitted
January 15, 2021
First Posted
January 20, 2021
Study Start
January 14, 2021
Primary Completion
September 14, 2025
Study Completion
September 14, 2025
Last Updated
August 6, 2024
Record last verified: 2024-08