HER2 Expression in Gynecological Malignant Tumors in Chon... | NCT06238284

Studies
HER2 Expression in Gynecological Malignant Tumors in Chongqing Area of China

NCT06238284

Sponsor

Chongqing University Cancer Hospital

Status

Unknown status

Last Update Posted

Feb 2, 2024Actual

Enrollment

300Estimated

Phase

Not provided

Conditions

Cervical Cancer
Endometrial Cancer
Ovarian Cancer
HER2 Expression

Interventions

no intervention

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 26, 2024Estimated

Primary Completion Date

Mar 31, 2024Estimated

Completion Date

May 31, 2024Estimated

First Submitted Date

Jan 25, 2024

First Submission Date that Met QC Criteria

Jan 25, 2024

First Posted Date

Feb 2, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 25, 2024

Last Update Posted Date

Feb 2, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

300Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Cervical Cancer Group			Other: no intervention
Endometrial Cancer Group			Other: no intervention
Ovarian Cancer Group			Other: no intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
no intervention	Other	Since it is a retrospective study, no intervention is needed.	Cervical Cancer Group Endometrial Cancer Group Ovarian Cancer Group

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Qi Zhou, PH.D	Contact	13708384529		qizhou9128@163.com

Overall Officials

Not provided

Locations

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D002583	Uterine Cervical Neoplasms
D016889	Endometrial Neoplasms
D010051	Ovarian Neoplasms

Ancestor Terms

ID	Term
D014594	Uterine Neoplasms
D005833	Genital Neoplasms, Female
D014565	Urogenital Neoplasms
D009371	Neoplasms by Site

Browse Leaves

Not provided

Browse Branches

Not provided