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Clinical Trial of Molecular Biomarkers in Women With Uterine Cervix Cancer

Sponsor
Charles Kunos (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05462951
Collaborator
(none)
30
Enrollment
1
Arm
29
Anticipated Duration (Months)

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Radiation: Standard
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
30 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Basic Science
Official Title:
Phase 0 Clinical Trial of Molecular Biomarkers in Women With Uterine Cervix Cancer
Anticipated Study Start Date :
Aug 1, 2022
Anticipated Primary Completion Date :
Aug 1, 2024
Anticipated Study Completion Date :
Dec 31, 2024

Arms and Interventions

Arm Intervention/Treatment
Other: Radiochemotherapy followed by brachytherapy

Standard daily radiotherapy plus weekly cisplatin followed by brachytherapy

Radiation: Standard
Radiation then brachytherapy

Outcome Measures

Primary Outcome Measures

  1. Biomarker [3 months posttherapy]

    deoxyribonucleotide levels

  2. Biomarker [3 months posttherapy]

    HPV DNA levels

  3. Biomarker [3 months posttherapy]

    Circulating tumor cell count

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Charles Kunos

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Charles Kunos, Professor, University of Kentucky
ClinicalTrials.gov Identifier:
NCT05462951
Other Study ID Numbers:
  • MCC-22-GYN-09
First Posted:
Jul 18, 2022
Last Update Posted:
Jul 18, 2022
Last Verified:
Jul 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Product Manufactured in and Exported from the U.S.:
No
Additional relevant MeSH terms:
Uterine Cervical Neoplasms

Study Results

No Results Posted as of Jul 18, 2022