NCT03853915

Brief Summary

Nearly all cervical cancers are caused by the human papilloma virus (HPV), which can be detected in cancer tissue by laboratory tests. There is evidence that the virus can also be detected from a blood sample to monitor the effects of treatment. Previous studies have shown that a special test called 18F-Fluorodeoxyglucose (FDG) Positron Emission Tomography/Computed Tomography (PET-CT) at 3 months after treatment may predict survival in cervical cancer. The purpose of this study is to see how well the FDG-PET Scan and blood tests for HPV can detect leftover cervical cancer cells after treatment. This study is not a particular form of treatment and patients will receive standard of care treatment.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
64

participants targeted

Target at P50-P75 for not_applicable

Timeline
20mo left

Started Apr 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress82%
Apr 2019Dec 2027

First Submitted

Initial submission to the registry

February 22, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 26, 2019

Completed
2 months until next milestone

Study Start

First participant enrolled

April 23, 2019

Completed
8.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2027

Last Updated

March 5, 2026

Status Verified

March 1, 2026

Enrollment Period

8.7 years

First QC Date

February 22, 2019

Last Update Submit

March 3, 2026

Conditions

Cervical Cancer

Keywords

Cervical CancerPET ScanHPV DNA

Outcome Measures

Primary Outcomes (1)

  • Progression-free survival rate

    The progression-free survival rate of patients with and without detectable plasma HPV DNA post treatment

    up to 5 years

Secondary Outcomes (1)

  • Plasma HPV DNA levels

    Up to 3 months

Study Arms (1)

FDG PET Scan

EXPERIMENTAL

\[F-18\] - FDG PET Scan and blood sample to measure HPV DNA

Diagnostic Test: [18-F]- FDG - PET

Interventions

[18-F]- FDG - PETDIAGNOSTIC_TEST

\[F-18\]-FDG Injection is an intravenous diagnostic radiopharmaceutical used for Positron Emission Tomography. While this is not the subject of investigation in this study, \[F-18\]-FDG will be used in the PET imaging assessment of study participants during their 3 month follow-up post-treatment.

FDG PET Scan

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Histologically confirmed squamous cell carcinoma, adenocarcinoma or adenosquamous carcinoma of the cervix, FIGO stage IB-IVA
  • Planned for radical radiotherapy and concurrent cisplatin chemotherapy.
  • Age ≥ 18 years.

You may not qualify if:

  • Evidence of distant metastases (suspicious paraaortic nodes below the renal vessels allowed if they will be encompassed within the radiation field)
  • Patients who have received any anticancer treatment for their cervical cancer.
  • Other cervical cancer tumor histologies (e.g. small cell, serous)
  • Contraindications to 18FDG PET-CT
  • Contraindication to radiotherapy (e.g. severe Crohn's disease)
  • Contraindication to chemotherapy (e.g. non-reversible renal failure)
  • History of another invasive malignancy, except for non-melanoma skin cancer or tumors curatively treated with no evidence of disease for ≥ 5 years.
  • Known pregnancy or lactating

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Health Network, The Princess Margaret

Toronto, Ontario, M5G 2M9, Canada

RECRUITING

Related Publications (1)

  • Han K, Zou J, Zhao Z, Baskurt Z, Zheng Y, Barnes E, Croke J, Ferguson SE, Fyles A, Gien L, Gladwish A, Lecavalier-Barsoum M, Lheureux S, Lukovic J, Mackay H, Marchand EL, Metser U, Milosevic M, Taggar AS, Bratman SV, Leung E. Clinical Validation of Human Papilloma Virus Circulating Tumor DNA for Early Detection of Residual Disease After Chemoradiation in Cervical Cancer. J Clin Oncol. 2024 Feb 1;42(4):431-440. doi: 10.1200/JCO.23.00954. Epub 2023 Nov 16.

    PMID: 37972346DERIVED

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Condition Hierarchy (Ancestors)

Uterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Central Study Contacts

Kathy Han, MD

CONTACT

416 946 4501kathy.han@rmp.uhn.ca

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Model Details: Newly diagnosed FIGO stage IB-IVA cervical cancer patients planned for definitive chemoradiation will be accrued to study and will have: 1. FDG PET Scan at 3 month time point. 2. Blood sample to measure HPV DNA at time point baseline, end of radiotherapy, 4-6 weeks and 3 months post completion of definitive radiotherapy.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 22, 2019

First Posted

February 26, 2019

Study Start

April 23, 2019

Primary Completion (Estimated)

December 30, 2027

Study Completion (Estimated)

December 30, 2027

Last Updated

March 5, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)