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A Prospective, Multi-center, Real-world Study of Ovarian Metastatic Colorectal Cancer Patients (proOMCRC)

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ClinicalTrials.gov Identifier: NCT04716257
Recruitment Status : Recruiting
First Posted : January 20, 2021
Last Update Posted : January 20, 2021
Sponsor:
Collaborators:
Sun Yat-sen University
Cancer Hospital of China Medical University, Liaoning Cancer Hospital & Institute
Changhai Hospital, Naval Medical University
Information provided by (Responsible Party):
Xiaofen Li, West China Hospital

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.

Condition or disease
Ovarian Metastasis Colorectal Cancer

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.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 400 participants
Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration: 3 Years
Official Title: Impact of Different Treatment Strategies on the Prognosis of Ovarian Metastatic Colorectal Cancer Patients: a Prospective, Multi-center, Real-world Study
Estimated Study Start Date : January 14, 2021
Estimated Primary Completion Date : January 14, 2024
Estimated Study Completion Date : January 14, 2024

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Ovarian specific objective response rate [ Time Frame: 6 months ]
    Response rate of ovarian metastases to systemic chemotherapy

  2. Extra-ovarian specific objective response rate [ Time Frame: 6 months ]
    Response rate of extra-ovarian metastases to systemic chemotherapy

  3. Progression free survival [ Time Frame: 6 months ]
    Survival time from treatment start to disease progression or death.

  4. Quality of life questionnaire [ Time Frame: 6 months ]
    Quality of life during treatment


Biospecimen Retention:   Samples With DNA
samples of ovarian metastases if available


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients diagnosed with ovarian metastatic colorectal cancer.
Criteria

Inclusion Criteria:

  1. Histologically confirmed colorectal adenocarcinoma;
  2. Histologically or radiologically diagnosed with ovarian metastasis, whether or not combined with metastases in other organs;
  3. Women ≥18 years of age;
  4. Eastern Cooperative Oncology Group performance status score ≤2;
  5. Available imaging data if the disease is measurable according to RECIST criteria version 1.1; patients are eligible if there is no measurable lesion.
  6. Complete medical records;
  7. Informed consent form signed.

Exclusion Criteria:

  1. Not ovarian metastatic colorectal cancer confirmed by radiology or histology;
  2. Drug abuse or other medical, psychological and social disorders that would interfere with cooperation with the requirements of the study;
  3. Other conditions that would influence patient compliance;
  4. Pregnant or breastfeeding female; male and female unwilling to take any contraceptive measures.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04716257


Contacts
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Contact: Xiaofen Li, M.D. +86-28-85422589 lxf0827@163.com

Locations
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China, Guangdong
Sun Yat-sen University Cancer Center Recruiting
Cantón, Guangdong, China, 510060
Contact: Peirong Ding, Ph.D.    020-87343533    dingpr@sysucc.org.cn   
China, Liaoning
Cancer Hospital of China Medical University, Liaoning Cancer Hospital & Institute Recruiting
Shenyang, Liaoning, China, 110042
Contact: Rui Zhang, Ph.D.    024-31916293    zhangrui@cancerhosp-ln-cmu.com   
China, Sichuan
West China Hospital of Sichuan University Recruiting
Chengdu, Sichuan, China, 610041
Contact: Xiaofen Li, M.D.    +86-28-85422589    lxf0827@163.com   
China
Changhai Hospital, Naval Medical University Recruiting
Shanghai, China, 200433
Contact: Wei Zhang, Ph.D.    021-31166666    weizhang2000cn@163.com   
Sponsors and Collaborators
West China Hospital
Sun Yat-sen University
Cancer Hospital of China Medical University, Liaoning Cancer Hospital & Institute
Changhai Hospital, Naval Medical University
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Responsible Party: Xiaofen Li, Dr., West China Hospital
ClinicalTrials.gov Identifier: NCT04716257    
Other Study ID Numbers: 20201296
First Posted: January 20, 2021    Key Record Dates
Last Update Posted: January 20, 2021
Last Verified: January 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Colorectal Neoplasms
Krukenberg Tumor
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Carcinoma, Signet Ring Cell
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms, Cystic, Mucinous, and Serous