Clinical trial · Observational
Human Papilloma Virus (HPV) Circulating Tumor DNA (ctDNA) in Cervical Cancer
NCT04574635CI-TRIAL-00096796active not recruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study collects blood samples to determine if the DNA of HPV that causes cervical cancer can be detected in patients with cervical cancer that is new (primary), has come back (recurrent), or has spread to other places in the body (metastatic) and are undergoing treatment with surgery, radiotherapy, chemotherapy, and/or immunotherapy. Researchers may use this information to predict response (good or bad) of the cervical cancer to treatment and detect recurrent cancer sooner.
Conditions
Conditions (27)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cervical Adenosquamous Carcinoma | Cervical Adenosquamous Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Cervical Squamous Cell Carcinoma, Not Otherwise Specified | Cervical Squamous Cell Carcinoma | CURATED_BROADER | 0.80 |
| Infiltrating Cervical Carcinoma | Invasive Cervical Carcinoma | ALIAS | 0.90 |
| Metastatic Cervical Carcinoma | Cervical Carcinoma | CURATED_BROADER | 0.78 |
| Recurrent Cervical Carcinoma | Cervical Carcinoma | CURATED_BROADER | 0.78 |
| Stage IA1 Cervical Cancer FIGO 2018 | — | UNRESOLVED | — |
| Stage IA2 Cervical Cancer FIGO 2018 | — | UNRESOLVED | — |
| Stage IA Cervical Cancer FIGO 2018 | — | UNRESOLVED | — |
| Stage IB1 Cervical Cancer AJCC v8 | Malignant Cervical Neoplasm |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Biospecimen Collection | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Definitive chemoradiotherapy patients
- description
- Patients undergo collection of blood samples at baseline prior to the first fraction of radiation, during week 4 of radiotherapy, on the day of the final fraction of radiotherapy, at 3 months post-radiotherapy, every 3 months during years 1 and 2, and at the time of recurrence (if applicable).
- interventionNames
- Procedure: Biospecimen Collection
Primary outcomes (1)
- measure
- Proportion of patients with undetectable circulating tumor deoxyribonucleic acid (ctDNA) posttreatment in patients with detectable ctDNA pre-treatment
- timeFrame
- At 6 weeks post-surgery (cohort 1), at 4-6 weeks after completion of chemotherapy and radiation (cohort 2), 4-6 weeks post End of chemotherapy and radiotherapy (cohort 3), at 8 weeks after start of chemotherapy or immunotherapy (cohort 4)
- description
- The proportion will be reported along with the exact 95% binomial confidence interval. Additionally will report the mean standard deviation and median interquartile range ctDNA post-treatment in these patients.
Secondary outcomes (7)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Able to provide written consent * Patient has given permission to give tumor/blood sample for research testing * Histological confirmation of adenocarcinoma, adenosquamous, or small cell carcinoma of the cervix * Known HPV status defined as positive staining for p16 on IHC or DNA ISH for HPV * Willingness to return to enrolling institution (Mayo Clinic Rochester or the University of Minnesota) for follow-up (during the Active Monitoring Phase of the study) or complete blood draws locally using study mail-in kits * Consent to allow blood specimens to be shared with Mayo Clinic study personnel and potential external collaborators for sample analysis * Definitive Chemoradiotherapy for Locally Advanced Disease (FIGO Stage IB2-IIIC) * FIGO 2019 Stage IB2-IIIC or not a surgical candidate * Plan to undergo definitive chemoradiotherapy including external beam radiotherapy, brachytherapy, and chemotherapy Exclusion Criteria: * Other active malignancy =\< 2 years prior to registration. * EXCEPTIONS: Non-melanotic skin cancer * NOTE: If there is a history or prior malignancy, they must not be receiving other specific treatment for cancer * Pregnancy or lactation * Inability on the part of the patient to understand the informed consent to be compliant with the protocol
References
Publications (0)
Data not yet available
No reference posted for this study.