NCT06238284

Brief Summary

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2024

Shorter than P25 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 25, 2024

Completed
1 day until next milestone

Study Start

First participant enrolled

January 26, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 2, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2024

Completed
Last Updated

February 2, 2024

Status Verified

June 1, 2023

Enrollment Period

2 months

First QC Date

January 25, 2024

Last Update Submit

January 25, 2024

Conditions

Cervical CancerEndometrial CancerOvarian CancerHER2 Expression

Keywords

Cervical CancerEndometrial CancerOvarian CancerHER2 ExpressionTherapeutic efficacyPrognosis

Outcome Measures

Primary Outcomes (1)

  • HER2 status

    HER2 exprssion level evaluated by pathologists

    from 2023.07 to 2024.05

Study Arms (3)

Cervical Cancer Group

Other: no intervention

Endometrial Cancer Group

Other: no intervention

Ovarian Cancer Group

Other: no intervention

Interventions

no interventionOTHER

Since it is a retrospective study, no intervention is needed.

Cervical Cancer GroupEndometrial Cancer GroupOvarian Cancer Group

Eligibility Criteria

Age18 Years - 75 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Uterine Cervical NeoplasmsEndometrial NeoplasmsOvarian Neoplasms

Condition Hierarchy (Ancestors)

Uterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesEndocrine Gland NeoplasmsOvarian DiseasesAdnexal DiseasesEndocrine System DiseasesGonadal Disorders

Central Study Contacts

Qi Zhou, PH.D

CONTACT

13708384529qizhou9128@163.com

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 25, 2024

First Posted

February 2, 2024

Study Start

January 26, 2024

Primary Completion

March 31, 2024

Study Completion

May 31, 2024

Last Updated

February 2, 2024

Record last verified: 2023-06