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Clinical Trial of Molecular Biomarkers in Women With Uterine Cervix Cancer

Primary Purpose

Uterine Cervix Cancer

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Standard

About this trial

This is an interventional basic science trial for Uterine Cervix Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

- Untreated pathologically or cytologically-confirmed diagnosis of stage IB3 (> 4cm), II, III, or IVA (FIGO 2018) squamous, adenosquamous, or adenocarcinoma of the uterine cervix not amenable to curative surgery alone.

Exclusion Criteria:

Presence of another concurrent active invasive malignancy
Prior invasive malignancy diagnosed within the last three years except for [1] non-melanoma skin cancer or [2] prior in situ carcinoma of the cervix
prior pelvic radiotherapy for any reason that would contribute radiation dose that would exceed tolerance of normal tissues at the discretion of the treating physician.

Sites / Locations

Markey Cancer CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Radiochemotherapy followed by brachytherapy

Arm Description

Standard daily radiotherapy plus weekly cisplatin followed by brachytherapy

Outcomes

Primary Outcome Measures

Biomarker

deoxyribonucleotide levels

Biomarker

HPV DNA levels

Biomarker

Circulating tumor cell count

Secondary Outcome Measures

Full Information

NCT ID

NCT05462951

First Posted

July 8, 2022

Last Updated

September 19, 2023

Sponsor

Denise Fabian

Collaborators

UK Radiopharma Alliance

1. Study Identification

Unique Protocol Identification Number

NCT05462951

Brief Title

Clinical Trial of Molecular Biomarkers in Women With Uterine Cervix Cancer

Official Title

Phase 0 Clinical Trial of Molecular Biomarkers in Women With Uterine Cervix Cancer

Study Type

Interventional

2. Study Status

Record Verification Date

September 2023

Overall Recruitment Status

Recruiting

Study Start Date

January 3, 2023 (Actual)

Primary Completion Date

August 1, 2024 (Anticipated)

Study Completion Date

December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Denise Fabian

Collaborators

UK Radiopharma Alliance

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

This is a phase 0 clinical trial of molecular biomarkers in women with uterine cervix cancer. Women receive standard-of-care radiochemotherapy followed by brachytherapy. Blood samples are obtained to detect circulating levels of deoxyribonucleotides, human papillomavirus DNA, and circulating tumor cells.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Uterine Cervix Cancer

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Radiochemotherapy followed by brachytherapy

Arm Type

Other

Arm Description

Standard daily radiotherapy plus weekly cisplatin followed by brachytherapy

Intervention Type

Radiation

Intervention Name(s)

Standard

Intervention Description

Radiation then brachytherapy

Primary Outcome Measure Information:

Title

Biomarker

Description

deoxyribonucleotide levels

Time Frame

3 months posttherapy

Title

Biomarker

Description

HPV DNA levels

Time Frame

3 months posttherapy

Title

Biomarker

Description

Circulating tumor cell count

Time Frame

3 months posttherapy

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: - Untreated pathologically or cytologically-confirmed diagnosis of stage IB3 (> 4cm), II, III, or IVA (FIGO 2018) squamous, adenosquamous, or adenocarcinoma of the uterine cervix not amenable to curative surgery alone. Exclusion Criteria: Presence of another concurrent active invasive malignancy Prior invasive malignancy diagnosed within the last three years except for [1] non-melanoma skin cancer or [2] prior in situ carcinoma of the cervix prior pelvic radiotherapy for any reason that would contribute radiation dose that would exceed tolerance of normal tissues at the discretion of the treating physician.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Yvonne Taul

Phone

859-323-2354

yvonne.taul@uky.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Denise Fabian, MD

Organizational Affiliation

University of Kentucky

Official's Role

Principal Investigator

Facility Information:

Facility Name

Markey Cancer Center

City

Lexington

State/Province

Kentucky

ZIP/Postal Code

40536

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Yvonne Taul, RN

Phone

859-323-2354

Yvonne.Taul@uky.edu

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Clinical Trial of Molecular Biomarkers in Women With Uterine Cervix Cancer

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