Anal High-Grade Squamous Intraepithelial Lesions Clinical Trial
Official title:
Validation of a Health-Related Symptom Index for Persons Diagnosed With and Either Treated or Monitored for Anal High-Grade Squamous Intraepithelial Lesions (HSIL)
| NCT number | NCT02836522 |
| Other study ID # | 16-282 |
| Secondary ID | |
| Status | Completed |
| Phase | |
| First received | |
| Last updated | |
| Start date | April 25, 2016 |
| Est. completion date | August 31, 2023 |
| Verified date | August 2023 |
| Source | Memorial Sloan Kettering Cancer Center |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
The purpose of this study is to finalize development of a questionnaire that measures health-related symptoms and concerns for persons diagnosed with, and either treated or monitored for, anal pre-cancer lesions.
| Status | Completed |
| Enrollment | 406 |
| Est. completion date | August 31, 2023 |
| Est. primary completion date | August 31, 2023 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 35 Years and older |
| Eligibility | Inclusion Criteria: - Consented to the ANCHOR trial as per self-report and by providing a valid referral code on the information sheet provided by the referring site. Both men and women from the ANCHOR trial will be recruited to this study. - English fluent as we are only validating this measure in English at this time - At least one month post-treatment for anal HSIL as per self-report, or if the person is in the ANCHOR trial observation arm, then at least one month post- randomization. - Within two weeks post initial-treatment for anal HSIL on ANCHOR study or within two weeks post-randomization to ANCHOR study as per self-report. NOTES: - ANCHOR participants who are randomized to the treatment arm must have completed initial treatment and are within two weeks of initial treatment completion. - ANCHOR participants who were treated initially with topical treatment are only eligible within two weeks after the last topical treatment application. - ANCHOR participants who were treated initially with both topical and ablation treatments are eligible within two weeks of completing both treatments. - ANCHOR participants who are randomized to the active monitoring arm are eligible if they are within two weeks of randomization Exclusion Criteria: - Has a scheduled ANCHOR follow-up appointment in the next two weeks as per self report. The purpose of this exclusion criterion is to minimize the impact on a participant's responses to a post-test evaluation the potential occurrence of an interim diagnosis or treatment event, or anxiety related to an upcoming medical follow-up. |
| Country | Name | City | State |
|---|---|---|---|
| United States | Northwestern University | Evanston | Illinois |
| United States | City College of New York | New York | New York |
| United States | Memorial Sloan - Kettering Cancer Center | New York | New York |
| United States | New York Presbyterian Hospital-Weill Medical College of Cornell University | New York | New York |
| Lead Sponsor | Collaborator |
|---|---|
| Memorial Sloan Kettering Cancer Center | Northwestern University, The City College of New York |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | degree of test-retest reliability in the ANCHOR HRSI | measure from the initial assessment point to the 7-10 day follow-up. | 7-10 days |