Clinical trial NCT04064515: CTCs in Cervix Cancer
Official title: Identification of Circulating Tumor Cells in Patients With HPV 16 or 18 Associated Cervical Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cervical Cancer
HPV
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2019-08-22
Enrollment: 4
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Two groups will be recruited: the case group will consist of 16 participants with advanced or recurrent cervical cancer; the control arm will consist of 16 participants without a history of cervical cancer or high grade pre-cancer of the cervix.

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
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:
measure: Presence of HPV 16 or 18 genome in the samples with a positive CTC result, in order to confirm a cervical cancer origin.
timeFrame: 3 Years
measure: Recurrence rates in patients stratified by CTC identification
timeFrame: 3 Years
Other outcomes:
Locations:
city: New York
country: United States
facility: NYU Langone Health
state: New York
Study officials:
affiliation: NYU Langone Health
name: Leslie Boyd, MD
role: PRINCIPAL_INVESTIGATOR
References: