|No phase specified||Biomarker/Laboratory analysis, Diagnostic||Active||18 and over||NCI, Other||CDR0000590397|
U01CA121947, AMC-058, NCT00695422
RATIONALE: Diagnostic procedures, such as anal swab collection, digital rectal examination, and anal endoscopy and biopsy, may help find and diagnose anal and genital human papillomavirus infection and squamous intraepithelial lesions and help doctors plan better treatment.
PURPOSE: This clinical trial is studying ways to detect anal and genital human papillomavirus infection and squamous intraepithelial lesions in HIV-positive patients enrolled in an AIDS cancer clinical trial.
Further Study Information
- To determine if various pharmacotherapeutic agents investigated in primary AIDS Malignancy Clinical Trials (AMC) for diseases other than human papillomavirus (HPV)-associated neoplasia have any preliminary evidence of activity against anogenital HPV infection or anogenital squamous intraepithelial lesions (ASIL) in HIV-positive patients participating in these trials.
- To describe changes in the types of anal HPV present and the prevalence of ASIL in patients treated on these studies.
- To evaluate cervical HPV infection and cervical/vulvovaginal disease in HIV-positive women participating in these trials.
- To describe changes in cervical HPV infection and cervical/vulvovaginal disease in these women after undergoing various study treatments.
OUTLINE: This is a multicenter study.
Patients undergo anal swab collection at baseline to obtain samples for anal cytology, anal human papillomavirus (HPV) typing, and other HPV-related testing (e.g., HPV viral load). Digital rectal examinations (DRE) are also performed as part of the baseline physical examination. Female patients also undergo cervical swab collection for cervical HPV testing and cytology, as well as colposcopy (if available) of the cervix and vulvovaginal region to completely assess lower genital tract HPV-related lesions. At sites where high-resolution anoscopy (HRA) is available, patients are encouraged, but not required, to have an HRA with biopsy of any visualized lesions within 30 days of collection of the swabs.
After baseline assessments, patients undergo treatment with the investigative agent according to the study protocol requirements. If study treatment continues beyond 6 months, additional anal and cervical swabs are obtained for anal and cervical HPV and cytology along with DREs every 6 months until completion of study treatment and at the final study visit. Patients may also undergo additional HRA with biopsy and/or colposcopy of the lower genital tract with biopsy (women only) at this time. Patients with an abnormal anal cytology or histology are referred for HRA per local standard of care. If HRA is not available at the treatment site, patients undergo a DRE, and those with an abnormal DRE are referred for evaluation by a surgeon.
- Serologic documentation of HIV infection by any FDA-approved tests
- Enrolled in an AIDS Malignancy Clinical Trials Consortium (AMC) clinical trial of any new or existing pharmacotherapeutic agent for treatment of disease other than human papillomavirus (HPV)-associated neoplasia
- AMC study must have an accrual target of > 15 patients
- ECOG performance status (PS) 0-1 OR Karnofsky PS 60-100%
- Life expectancy ≥ 3 months
- Not pregnant or nursing
- Patients receiving myelosuppressive therapy must meet the following criteria:
- ANC > 1,000/μL
- Platelet count > 50,000/μL
- Evaluated before treatment or completely recovered from their nadir
- Able to understand and willing to sign a written informed consent document
- No bleeding disorder or requirement for anticoagulation that would contraindicate any biopsy of the anal canal
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
Trial Lead Organizations/Sponsors
AIDS Associated Malignancies Clinical Trials ConsortiumNational Cancer Institute
|J. Michael Berry||Principal Investigator|
|J. Michael Berry, MD||Ph: 877-827-3222|
|Rebecca and John Moores UCSD Cancer Center|
|Clinical Trials Office - Rebecca and John Moores UCSD Cancer||Ph: 858-822-5354|
|UCLA Clinical AIDS Research and Education (CARE) Center|
|Ronald T. Mitsuyasu, MD||Ph: 310-557-1893|
|USC/Norris Comprehensive Cancer Center and Hospital|
|Clinical Trials Office - USC/Norris Comprehensive Cancer Cente||Ph: 323-865-0451|
|UCSF Helen Diller Family Comprehensive Cancer Center|
|Clinical Trials Office - UCSF Helen Diller Family Comprehensi||Ph: 877-827-3222|
|Cancer Research Center of Hawaii|
|Clinical Trials Office - Cancer Research Center of Hawaii||Ph: 808-586-2979|
|Beth Israel Deaconess Medical Center|
|Clinical Trials Office - Beth Israel Deaconess Medical Center||Ph: 617-667-9925|
|Boston University Cancer Research Center|
|Clinical Trials Office - Boston University Cancer Research Cen||Ph: 617-638-8265|
|Memorial Sloan-Kettering Cancer Center|
|Mark Dickson, MD||Ph: 212-639-5218|
|Baylor University Medical Center - Houston|
|Elizabeth Y. Chiao, MD, MPH||Ph: 713-798-8070|
|Benaroya Research Institute at Virginia Mason Medical Center|
|Clinical Trials Office - Benaroya Research Institute||Ph: 206-583-6526|
Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00695422
ClinicalTrials.gov processed this data on October 17, 2013
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