Immune Repertoire of Ovarian HGSC

January 3, 2019 updated by: Lei Li

Differential Expression of Immune Repertoire of T/B Lymphocytes in Ovarian High Grade Serous Carcinoma

In this preliminary study, peripheral blood and carcinoma tissue with pericarcinomatous tissue are taken from the patients with ovarian high grade serous carcinoma at several points: before any treatment, after the debulking surgery, and after all the proposed chemotherapy. The differential expression of the T/B lymphocyte receptors in these samples will be analyzed with the platinum-based treatment and survival outcomes of the patients. The primary objective is the expression rates of T/B lymphocyte receptors in different stages of checking points.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100730
        • Recruiting
        • Lei Li

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Patients confirmed of primary ovarian high grade serous carcinoma, aged 18 years or older and accept systematic treatment including debulking surgery and platinum-based chemotherapy.

Description

Inclusion Criteria:

  • Confirmed of primary ovarian high grade serous carcinoma
  • Aged 18 years or older
  • No immunosuppressive disease
  • Signed an approved informed consents

Exclusion Criteria:

  • Not meeting all of the inclusion criteria

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Expression rates of T lymphocyte receptors
Time Frame: One year
Expression rates of T lymphocyte receptors in different stages of checking points, including timings before any treatment, after the debulking surgery, and after all the proposed chemotherapy
One year
Expression rates of B lymphocyte receptors
Time Frame: One year
Expression rates of T lymphocyte receptors in different stages of checking points, including timings before any treatment, after the debulking surgery, and after all the proposed chemotherapy
One year

Collaborators and Investigators

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

Sponsor

Lei Li

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 (Actual)

January 3, 2019

Primary Completion (Anticipated)

January 1, 2021

Study Completion (Anticipated)

January 1, 2022

Study Registration Dates

First Submitted

January 3, 2019

First Submitted That Met QC Criteria

January 3, 2019

First Posted (Actual)

January 4, 2019

Study Record Updates

Last Update Posted (Actual)

January 4, 2019

Last Update Submitted That Met QC Criteria

January 3, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EOC-IMMUNE

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

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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