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CTCs in Cervix Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04064515
Recruitment Status : Not yet recruiting
First Posted : August 22, 2019
Last Update Posted : August 22, 2019
Sponsor:
Information provided by (Responsible Party):
NYU Langone Health

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.

Condition or disease Intervention/treatment
Parkinson Disease Diagnostic Test: Blood Assayed for CTCs

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Study Type : Observational
Estimated Enrollment : 32 participants
Observational Model: Cohort
Time Perspective: Other
Official Title: Identification of Circulating Tumor Cells in Patients With HPV 16 or 18 Associated Cervical Cancer
Estimated Study Start Date : September 2019
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : September 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cervical Cancer

Group/Cohort Intervention/treatment
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
All study participants will have 15 mL of blood drawn for the purpose of the study.

Control
Participants without a history of cervical cancer or high grade pre-cancer of the cervix
Diagnostic Test: Blood Assayed for CTCs
All study participants will have 15 mL of blood drawn for the purpose of the study.




Primary Outcome Measures :
  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 Outcome Measures :
  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 ]

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.


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Woman age 18 or older, with pathologically confirmed invasive cervical cancer
Accepts Healthy Volunteers:   No
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.
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.
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Responsible Party: NYU Langone Health
ClinicalTrials.gov Identifier: NCT04064515    
Other Study ID Numbers: 19-00495
First Posted: August 22, 2019    Key Record Dates
Last Update Posted: August 22, 2019
Last Verified: August 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases