Clinicopathologic and Ancillary Testing of Primary Clear Cell Carcinoma of the Cervix
Sponsor
M.D. Anderson Cancer Center (Other)
Overall Status
Recruiting
CT.gov ID
NCT05046080
Collaborator
(none)
70
1
13.8
5.1
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Detailed Description
PRIMARY OBJECTIVE:
- 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.
Study Design
Study Type:
Observational
Anticipated Enrollment
:
70 participants
Observational Model:
Case-Only
Time Perspective:
Retrospective
Official Title:
Clinicopathologic and Ancillary Testing of Primary Clear Cell Carcinoma of the Cervix - a Rare Tumor
Actual Study Start Date
:
Aug 6, 2021
Anticipated Primary Completion Date
:
Sep 29, 2022
Anticipated Study Completion Date
:
Sep 29, 2022
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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
Medical records reviewed
Other: Laboratory Biomarker Analysis
Correlative studies
|
Outcome Measures
Primary Outcome Measures
- Clinicopathologic study on patients diagnosed and treated for clear cell carcinoma of the cervix [through study completion, an average of 1 year]
Eligibility Criteria
Criteria
Ages Eligible for Study:
N/A
and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
Inclusion Criteria:
- Patients diagnosed with clear cell carcinoma of the cervix at MDACC
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | M D Anderson Cancer Center | Houston | Texas | United States | 77030 |
Sponsors and Collaborators
- M.D. Anderson Cancer Center
Investigators
- Principal Investigator: Anasis Malpica, M.D. Anderson Cancer Center
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.Responsible Party:
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT05046080
Other Study ID Numbers:
- 2020-0989
- NCI-2021-08814
- 2020-0989
First Posted:
Sep 16, 2021
Last Update Posted:
Aug 22, 2022
Last Verified:
Aug 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms: