Ovarian MetastasisproOMCRCNCT04716257
A Prospective, Multi-center, Real-world Study of Ovarian Metastatic Colorectal Cancer Patients
An observational study of Ovarian Metastasis and Colorectal Cancer, run by West China Hospital at 4 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Ovarian Metastasis, Colorectal Cancer
- How many people
- 400 participants
- Where
- 4 sitesChina
- Study dates
- 14 Jan 2021to 14 Sep 2025
- How long will I take part?
- 3 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Patients diagnosed with ovarian metastatic colorectal cancer.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
4 sites in 1 country.
China4 sites, 4 recruiting
- Recruiting
West China Hospital of Sichuan University
Chengdu, Sichuan, 610041
Meng Qiu, M.D., +86-28-85422589, hxqmtg@163.com
- Recruiting
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 510060
Peirong Ding, Ph.D., 020-87343533, dingpr@sysucc.org.cn
- Recruiting
Changhai Hospital, Naval Medical University
Shanghai, 200433
Wei Zhang, Ph.D., 021-31166666, weizhang2000cn@163.com
- Recruiting
Cancer Hospital of China Medical University, Liaoning Cancer Hospital & Institute
Shenyang, Liaoning, 110042
Rui Zhang, Ph.D., 024-31916293, zhangrui@cancerhosp-ln-cmu.com
About this study
Official title: Impact of Different Treatment Strategies on the Prognosis of Ovarian Metastatic Colorectal Cancer Patients: a Prospective, Multi-center, Real-world Study
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.
Read the detailed description
This study prospectively collects data of patients diagnosed with ovarian metastatic colorectal cancer, meeting inclusion criteria and signing the informed consent. Patients' treatment strategies and survival outcome in the real world will be faithfully recorded.
- Conditions
- Ovarian Metastasis, Colorectal Cancer
- Medical subject headings
- Krukenberg Tumor, Colorectal Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Ovarian specific overall survival
Calculated from the date of diagnosis with ovarian metastasis to death (caused by cancer) or last follow-up time.
Measured: up to 3 years
Secondary outcomes (4)
Ovarian specific objective response rate
Response rate of ovarian metastases to systemic chemotherapy
Measured: 6 months
Extra-ovarian specific objective response rate
Response rate of extra-ovarian metastases to systemic chemotherapy
Measured: 6 months
Progression free survival
Survival time from treatment start to disease progression or death.
Measured: 6 months
Quality of life questionnaire
Quality of life during treatment
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2021
- Study start14 Jan 2021
- Primary completion14 Sep 2025 (estimated)
- Study completion14 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian MetastasisStudies of the same condition, open and under way.
- More trials run by West China HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 400 participants (estimated)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- West China Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Sun Yat-sen University, Liaoning Cancer Hospital & Institute, Changhai Hospital
- Responsible party
- Principal investigator, Meng Qiu, West China Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04716257
- Sponsor's protocol ID
- 20201296
- Acronym
- proOMCRC
- Status last verified
- Aug 2024
- First submitted
- 15 Jan 2021
- Last updated
- 6 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Different Treatment Strategies on the Prognosis of Ovarian Metastatic Colorectal Cancer Patients: a Prospective, Multi-center, Real-world Study
- ClinicalTrials.gov ID
- NCT04716257
- Acronym / sponsor ID
- proOMCRC / 20201296
- Conditions
- Ovarian Metastasis, Colorectal Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- West China HospitalUniversity, hospital or other
- Collaborators
- Sun Yat-sen University, Liaoning Cancer Hospital & Institute, Changhai Hospital
- Study start
- 14 Jan 2021 (actual)
- Primary completion
- 14 Sep 2025 (estimated)
- Study completion
- 14 Sep 2025 (estimated)
- First posted
- 20 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This study prospectively collects data of patients diagnosed with ovarian metastatic colorectal cancer, meeting inclusion criteria and signing the informed consent. Patients' treatment strategies and survival outcome in the real world will be faithfully recorded.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 3 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients diagnosed with ovarian metastatic colorectal cancer.
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Ovarian specific overall survival
Time frame: up to 3 years
Calculated from the date of diagnosis with ovarian metastasis to death (caused by cancer) or last follow-up time.
4 secondary outcomes
Ovarian specific objective response rate
Time frame: 6 months
Extra-ovarian specific objective response rate
Time frame: 6 months
Progression free survival
Time frame: 6 months
Quality of life questionnaire
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ovarian Metastasis and Colorectal Cancer, run by West China Hospital at 4 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Meng Qiu, M.D. (+86-28-85422589, hxqmtg@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ovarian specific overall survival (time frame: up to 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2024.