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OpenTrials
Completed

NCT Number: NCT04064515

CTCs in Cervix Cancer

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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Blood Assayed for CTCs

Diagnostic Test

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

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).

    Time frame: 3 Years

Secondary outcomes

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

    Time frame: 3 Years

  2. Recurrence rates in patients stratified by CTC identification

    Time frame: 3 Years

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Registry information

Official study title

Identification of Circulating Tumor Cells in Patients With HPV 16 or 18 Associated Cervical Cancer

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Aug 22, 2019
Registry last updated
Aug 5, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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