Clinical trial · Interventional
FDG-PET and Circulating HPV in Patients With Cervical Cancer
FDG-PET and Circulating HPV in Patients With Cervical Cancer Treated With Definitive Chemoradiation
- 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)
The addition of concurrent chemotherapy to definitive radiation has improved the 5-year survival of women with locally advanced cervical cancer to 58%. To determine if plasma HPV DNA predates clinical recurrence and/or improves the accuracy of metabolic response on FDG-PET at 3 months post completion of radical chemo-radiation in patients with locally advanced cervical cancer. Post therapy FDG-PET can help predict progression free survival and overall survival. In addition plasma HPV can be used to monitor response and detect early recurrence. Prospective study will recruit 20 patients with locally advanced cervical cancer to determine if plasma HPV DNA predates clinical recurrence and/or improves the accuracy response on post-therapy FDG-PET scan at 3 months.
Conditions
Conditions (1)
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 Cancer | Malignant Cervical Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cervical swab | Procedure | — | UNRESOLVED |
| PET-CT | Radiation | — | UNRESOLVED |
| Plasma HPV | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Cervical Swab, PET-CT and plasma HPV
- description
- Participants will have a cervical swab, and plasma HPV at baseline. In addition, a plasma HPV test drawn after completion of radiation. 3 months post chemoradiation, patients will have a PET-CT and plasma HPV completed. Plasma HPV will be drawn at progression/recurrence, if applicable.
- interventionNames
- Procedure: Cervical swab
- Radiation: PET-CT
- Biological: Plasma HPV
Primary outcomes (1)
- measure
- Change from baseline in plasma HPV DNA to 3 months.
- timeFrame
- Pre treatment and within the first 3 months post treatment
- description
- To determine if HPV DNA predates clinical recurrence and/or improves the accuracy of metabolic response on FDG-PET scan at 3 months post completion of radical chemoradiation in patients with locally advanced cervical cancer
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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. * Life expectancy of greater than 3 months. Exclusion Criteria: * 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. * Eastern Cooperative Oncology Group (ECOG) performance status \> 2 * Other cervical cancer tumor histologies (e.g. small cell, serous) * Contraindications to 18FDG PET-CT * Inability to lie supine for radiation and/or 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
References
Publications (0)
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