Prospective Multi-omics Observational Study of Gynecological Rare Pathological Tumors

Sponsor
RenJi Hospital (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05985941
Collaborator
(none)
600
57

Study Details

Study Description

Brief Summary

The goal of this observational study is to draw the characteristic maps of genomics, transcriptome, proteomics, metabolomics, etc. in 600 patients with gynecological rare pathological types of malignant tumors. Then it is planned to explore the molecular mechanism and find some new targets for diagnosis and treatment, and design and establish the database system of the above rare tumors.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    600 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Prospective Multi-omics Observational Study of Gynecological Rare Pathological Tumors
    Anticipated Study Start Date :
    Aug 1, 2023
    Anticipated Primary Completion Date :
    May 1, 2028
    Anticipated Study Completion Date :
    May 1, 2028

    Outcome Measures

    Primary Outcome Measures

    1. Multi-omics feature map [August 2023 to May 2028]

      Draw the characteristic maps of imaging omics, genomics, transcriptome, proteomics, pathological omics, metabolomics, etc. of patients with gynecological rare pathological types of malignant tumors, and explore the molecular mechanism thus finding some new targets for diagnosis and treatment.

    2. Database system [August 2023 to May 2028]

      Design and establish the database system of the above gynecological rare pathological types of tumors.

    Secondary Outcome Measures

    1. Correlation analysis [August 2023 to May 2028]

      Integrate the characteristic maps of imaging omics, genomics, transcriptome, proteomics, pathological omics, metabonomics, etc. to study their possible relevance.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • 1)Pathological diagnosis: clear cell carcinoma (ovary, uterus), nerve small-cell carcinoma (ovary, uterus), carcinosarcoma or sarcoma (ovary, uterus), cervical gastric adenocarcinoma, ovarian germ cell tumor, ovarian sex cord stromal tumor, trophoblastic tumor, perivascular epithelioid cell tumor (PECOMA) and other rare gynecological tumors; 2)Received pathological results from tumor surgery; 3)The patient voluntarily participated in this research project with good compliance and was able to complete the enrollment according to the experimental requirements; 4)Sign the informed consent form and consent to the collection and use of their data, and consent to genomics, transcriptome and other tests.
    Exclusion Criteria:
    • 1)Patients with malignant tumors in other parts of the body; 2)Suffering from uncontrollable neurological diseases, psychiatric diseases, or psychiatric disorders; 3)Poor compliance and inability to cooperate and describe treatment responders.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • RenJi Hospital

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    RenJi Hospital
    ClinicalTrials.gov Identifier:
    NCT05985941
    Other Study ID Numbers:
    • LY2023-110-A
    First Posted:
    Aug 14, 2023
    Last Update Posted:
    Aug 14, 2023
    Last Verified:
    Aug 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by RenJi Hospital

    Study Results

    No Results Posted as of Aug 14, 2023