Prospective Multi-omics Observational Study of Gynecological Rare Pathological Tumors

August 3, 2023 updated by: RenJi Hospital
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.

Study Overview

Status

Not yet recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

600

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with rare gynecological tumors who underwent surgery in three hospitals, including Renji Hospital affiliated to Shanghai Jiaotong University School of Medicine, Sun Yat-sen Memorial Hospital affiliated to Sun Yat-sen University and the First Affiliated Hospital of University of Science and Technology of China, were diagnosed as clear cell carcinoma (ovary, uterus), neural small-cell carcinoma (ovary, uterus), carcinosarcoma or sarcoma (ovary, uterus), cervical gastric adenocarcinoma, ovarian germ cell tumor, ovarian sex cord stromal tumors, trophoblastic tumors, or perivascular epithelioid cell tumors (PECOMA), among others.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Multi-omics feature map
Time Frame: 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.
August 2023 to May 2028
Database system
Time Frame: August 2023 to May 2028
Design and establish the database system of the above gynecological rare pathological types of tumors.
August 2023 to May 2028

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correlation analysis
Time Frame: August 2023 to May 2028
Integrate the characteristic maps of imaging omics, genomics, transcriptome, proteomics, pathological omics, metabonomics, etc. to study their possible relevance.
August 2023 to May 2028

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

RenJi Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

August 1, 2023

Primary Completion (Estimated)

May 1, 2028

Study Completion (Estimated)

May 1, 2028

Study Registration Dates

First Submitted

August 3, 2023

First Submitted That Met QC Criteria

August 3, 2023

First Posted (Actual)

August 14, 2023

Study Record Updates

Last Update Posted (Actual)

August 14, 2023

Last Update Submitted That Met QC Criteria

August 3, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • LY2023-110-A

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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