Clinicopathologic and Ancillary Testing of Primary Clear... | NCT05046080

Studies
Clinicopathologic and Ancillary Testing of Primary Clear Cell Carcinoma of the Cervix

NCT05046080

Sponsor

M.D. Anderson Cancer Center

Status

Recruiting

Last Update Posted

Feb 19, 2026Actual

Enrollment

70Estimated

Phase

Not provided

Conditions

Human Papillomavirus-Independent Cervical Adenocarcinoma, Clear Cell-Type

Interventions

Electronic Health Record Review
Laboratory Biomarker Analysis

Countries

United States

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

ID	Type	Description	Link
NCI-2021-08814	Registry Identifier	CTRP (Clinical Trial Reporting Program)
2020-0989	Other Identifier	M D Anderson Cancer Center

Status Module

Record Verification Date

Feb 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 6, 2021Actual

Primary Completion Date

Sep 29, 2026Estimated

Completion Date

Sep 29, 2026Estimated

First Submitted Date

Aug 25, 2021

First Submission Date that Met QC Criteria

Sep 13, 2021

First Posted Date

Sep 16, 2021Actual

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

Feb 17, 2026

Last Update Posted Date

Feb 19, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

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 provide a comprehensive report on clinicopathologic features, immunohistochemical/biomarker testing and molecular profile of cervical clear cell carcinoma. This study may help researchers learn more about the molecular profile of cervical clear cell carcinoma.

Detailed Description

PRIMARY OBJECTIVE:

I. To perform a retrospective clinicopathologic study on patients diagnosed and treated for clear cell carcinoma of the cervix at M D Anderson Cancer Center (MDACC) and to delineate the immunohistochemical and molecular profile of these cases.

OUTLINE:

Patients' medical records are reviewed retrospectively, and archival tumor tissue analyzed by immunohistochemistry and next generation sequencing.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

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

70Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Observational (medical record review)		Patients' medical records are reviewed retrospectively, and archival tumor tissue analyzed by immunohistochemistry and next generation sequencing.	Other: Electronic Health Record Review Other: Laboratory Biomarker Analysis

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Electronic Health Record Review	Other	Medical records reviewed	Observational (medical record review)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Clinicopathologic study on patients diagnosed and treated for clear cell carcinoma of the cervix		through study completion, an average of 1 year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients diagnosed with clear cell carcinoma of the cervix at MDACC

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Patients diagnosed with clear cell carcinoma of the cervix, from January 1, 1985 to July 1, 2020

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Anasis Malpica	M.D. Anderson Cancer Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
M D Anderson Cancer Center	Recruiting	Houston	Texas	77030	United States