Cervical CancerNCT04064515
CTCs in Cervix Cancer
An observational study of Cervical Cancer and HPV, run by NYU Langone Health at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 years, women only
- Conditions the study is for
- Cervical Cancer, HPV
- What is being tested?
- Blood Assayed for CTCs
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Mar 2020to 23 Apr 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- Women only
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
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- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Identification of Circulating Tumor Cells in Patients With HPV 16 or 18 Associated Cervical 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.
- Conditions
- Cervical Cancer, HPV
- Being tested
- Blood Assayed for CTCs
- Medical subject headings
- Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood Assayed for CTCsDiagnostic test
All study participants will have 15 mL of blood drawn for the purpose of the study.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: Blood Assayed for CTCs | |
| Control | Participants without a history of cervical cancer or high grade pre-cancer of the cervix Receives: Diagnostic Test: Blood Assayed for CTCs |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: 3 Years
Recurrence rates in patients stratified by CTC identification
Measured: 3 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2019
- Study start2 Mar 2020
- Primary completion23 Apr 2020
- Study completion23 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical CancerStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Leslie Boyd, MD, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04064515
- Sponsor's protocol ID
- 19-00495
- Status last verified
- Aug 2022
- First submitted
- 20 Aug 2019
- Last updated
- 5 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification of Circulating Tumor Cells in Patients With HPV 16 or 18 Associated Cervical Cancer
- ClinicalTrials.gov ID
- NCT04064515
- Acronym / sponsor ID
- 19-00495
- Conditions
- Cervical Cancer, HPV
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 4 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- 2 Mar 2020 (actual)
- Primary completion
- 23 Apr 2020 (actual)
- Study completion
- 23 Apr 2020 (actual)
- First posted
- 22 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cervical Cancer | – | Diagnostic Test: Blood Assayed for CTCsParticipants 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. |
| Control | – | Diagnostic Test: Blood Assayed for CTCsParticipants without a history of cervical cancer or high grade pre-cancer of the cervix |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood Assayed for CTCsAll study participants will have 15 mL of blood drawn for the purpose of the study. | Diagnostic test | Cervical Cancer, Control |
Primary outcome
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
2 secondary outcomes
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
Recurrence rates in patients stratified by CTC identification
Time frame: 3 Years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Leslie Boyd, MD principal investigator
NYU Langone Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cervical Cancer and HPV, run by NYU Langone Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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). (time frame: 3 Years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2022.