Clinical trial · Observational
CTCs in Cervix Cancer
Identification of Circulating Tumor Cells in Patients With HPV 16 or 18 Associated Cervical Cancer
NCT04064515CI-TRIAL-00060143completedClinicalTrials.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 is a validation study to confirm the ability of Telomescan OBP-401 to identify CTCs in patients with HPV 16 / 18 associated cervical cancer. CTCs identified will be tested for the presence of the HPV 16 / 18 E6 protein, confirming a cervical cancer origin.
Conditions
Conditions (2)
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 |
| HPV | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Blood Assayed for CTCs | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Cervical Cancer
- description
- Participants with advanced or recurrent cervical cancer will provide 15 mL of whole blood. Participants will then be followed prospectively for three years to document oncologic outcome.
- interventionNames
- Diagnostic Test: Blood Assayed for CTCs
- label
- Control
- description
- Participants without a history of cervical cancer or high grade pre-cancer of the cervix
- interventionNames
- Diagnostic Test: Blood Assayed for CTCs
Primary outcomes (1)
- measure
- Effectiveness of OBP-401 to identify CTCs in patients with active HPV 16 / 18 associated cervical cancer compared to non-cancer controls (patients without CIN 2 - 3 or cancer).
- timeFrame
- 3 Years
Secondary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 100 Years
Show eligibility criteria text
Inclusion Criteria: * Able to safely provide 15 ml of blood * Able to provide informed consent * Pathologically confirmed invasive cervical cancer * Proof of serotype HPV 16 or HPV 18 positive within 3 years of the study * Patients with stages IIA2 to IVB OR recurrent cervical cancer * For patients with newly diagnosed cervical cancer, they must be enrolled (blood drawn) prior to initiating anti-cancer therapy * For patients with recurrent cervical cancer, they must be enrolled (blood drawn) prior to initiating a new anti-cancer therapy for progression of disease (based on RECIST 1.1 criteria). Patients who have progressed and are moving to best supportive care are eligible. * If patients meet criteria 5.1A 5 above, the following criteria must be met: * At least 21 days have elapsed following treatment with cytotoxic chemotherapy * At least 14 days have elapsed following treatment with biologic therapy * At least 14 days have elapsed following radiation therapy Exclusion Criteria: * History of any cancer other than cervix cancer within the past five years. * History of any known germ-line pathogenic mutation (ie BRCA 1 / 2 or Lynch syndrome, but genetic testing is not required) * Current use of systemic corticosteroids at doses exceeding 10 mg per day of prednisone or its equivalent. * Active infection including hepatitis B, hepatitis C, HIV. * Any patient unable to comply with the study criteria. * Patients taking any anti-inflammatory agents (aspirin, NSAIDs, steroids), within 24 hrs prior to blood draw.
References
Publications (0)
Data not yet available
No reference posted for this study.