CTCs in Cervix Cancer (NCT04064515) | Clinical Trial Compass
CompletedNot Applicable
CTCs in Cervix Cancer
United States4 participantsStarted 2020-03-02
Plain-language summary
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.
Who can participate
Age range18 Years – 100 Years
SexFEMALE
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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), …
What they're measuring
1
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).