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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
| |
| Control | Participants without a history of cervical cancer or high grade pre-cancer of the cervix |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blood Assayed for CTCs | Diagnostic Test | All study participants will have 15 mL of blood drawn for the purpose of the study. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
Woman age 18 or older, with pathologically confirmed invasive cervical cancer
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.
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| Name | Affiliation | Role |
|---|---|---|
| Leslie Boyd, MD | NYU Langone Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NYU Langone Health | New York | New York | 10016 | United States |
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| ID | Term |
|---|---|
| D002583 | Uterine Cervical Neoplasms |
| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
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DNA will be used to test CTCs identified for the presence of the HPV 16 / 18 E6 protein, confirming a cervical cancer origin.
| D009369 |
| Neoplasms |
| D002577 | Uterine Cervical Diseases |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |