HER2 Expression in Gynecological Malignant Tumors in Chongqing Area of China

January 25, 2024 updated by: Chongqing University Cancer Hospital
This study aims to retrospectively analyze the HER2 expression of gynecological malignant tumors in Chongqing by immunohistochemical detection, and explore the correlation between HER2 level, therapy response and prognosis based on patient clinical information.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

300

Contacts and Locations

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

Study Contact

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

Probability Sample

Study Population

Women with cervical adenocarcinoma (including carcinosarcoma), adenocarcinoma of uterus (including carcinosarcoma), or ovarian cancer, etc.

Description

Inclusion Criteria:

  • Patients with primary gynecological malignant tumor confirmed by histopathology
  • Women aged 18-75
  • The expected survival time is greater than 12 weeks
  • KPS > 60, ECOG score is 0-2
  • All subjects voluntarily joined this study with informed consents, and had good compliance of follow-up

Exclusion Criteria:

  • Pregnant and lactating women
  • Suffering from other malignant tumors in the past 5 years
  • Patients who are not suitable for this study according to the investigator's judgment

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Cervical Cancer Group
Other: no intervention
Since it is a retrospective study, no intervention is needed.
Endometrial Cancer Group
Other: no intervention
Since it is a retrospective study, no intervention is needed.
Ovarian Cancer Group
Other: no intervention
Since it is a retrospective study, no intervention is needed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
HER2 status
Time Frame: from 2023.07 to 2024.05
HER2 exprssion level evaluated by pathologists
from 2023.07 to 2024.05

Collaborators and Investigators

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

Sponsor

Chongqing University Cancer 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)

January 26, 2024

Primary Completion (Estimated)

March 31, 2024

Study Completion (Estimated)

May 31, 2024

Study Registration Dates

First Submitted

January 25, 2024

First Submitted That Met QC Criteria

January 25, 2024

First Posted (Actual)

February 2, 2024

Study Record Updates

Last Update Posted (Actual)

February 2, 2024

Last Update Submitted That Met QC Criteria

January 25, 2024

Last Verified

June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CQ-HER2-GYN

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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