NCT04064515

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 20, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 22, 2019

Completed
6 months until next milestone

Study Start

First participant enrolled

March 2, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 23, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 23, 2020

Completed
Last Updated

August 5, 2022

Status Verified

August 1, 2022

Enrollment Period

2 months

First QC Date

August 20, 2019

Last Update Submit

August 4, 2022

Conditions

Cervical CancerHPV

Outcome Measures

Primary Outcomes (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).

    3 Years

Secondary Outcomes (2)

  • Presence of HPV 16 or 18 genome in the samples with a positive CTC result, in order to confirm a cervical cancer origin.

    3 Years

  • Recurrence rates in patients stratified by CTC identification

    3 Years

Study Arms (2)

Cervical Cancer

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.

Diagnostic Test: Blood Assayed for CTCs

Control

Participants without a history of cervical cancer or high grade pre-cancer of the cervix

Diagnostic Test: Blood Assayed for CTCs

Interventions

Blood Assayed for CTCsDIAGNOSTIC_TEST

All study participants will have 15 mL of blood drawn for the purpose of the study.

Cervical CancerControl

Eligibility Criteria

Age18 Years - 100 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsWoman age 18 or older, with pathologically confirmed invasive cervical cancer
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

NYU Langone Health

New York, New York, 10016, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

DNA will be used to test CTCs identified for the presence of the HPV 16 / 18 E6 protein, confirming a cervical cancer origin.

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Condition Hierarchy (Ancestors)

Uterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Study Officials

  • Leslie Boyd, MD

    NYU Langone Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 20, 2019

First Posted

August 22, 2019

Study Start

March 2, 2020

Primary Completion

April 23, 2020

Study Completion

April 23, 2020

Last Updated

August 5, 2022

Record last verified: 2022-08

Locations

US(1)