NCT00695422

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
47

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2008

Longer than P75 for all trials

Geographic Reach
1 country

10 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 14, 2008

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

June 7, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 11, 2008

Completed
8.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 19, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 19, 2017

Completed
Last Updated

August 10, 2020

Status Verified

August 1, 2020

Enrollment Period

8.9 years

First QC Date

June 7, 2008

Last Update Submit

August 7, 2020

Conditions

Aids-related MalignanciesLymphomaPrecancerous ConditionSarcoma

Keywords

high-grade squamous intraepithelial lesionlow-grade squamous intraepithelial lesionhuman papilloma virus infectionAIDS-related diffuse large cell lymphomaAIDS-related diffuse mixed cell lymphomaAIDS-related diffuse small cleaved cell lymphomaAIDS-related immunoblastic large cell lymphomaAIDS-related Kaposi sarcomaAIDS-related lymphoblastic lymphomaAIDS-related malignanciesAIDS-related peripheral/systemic lymphomaAIDS-related primary CNS lymphomaAIDS-related small noncleaved cell lymphomamulticentric Castleman diseaseHIV Infections

Outcome Measures

Primary Outcomes (5)

  • Activity of pharmacotherapeutic agents being investigated in AIDS Malignancy Clinical Trials (AMC) against anogenital human papillomavirus (HPV) infection or anogenital squamous intraepithelial lesions (ASIL)

    Baseline, every 6 months while on parent protocol, treatment discontinuation on parent protocol, final visit on parent protocol

  • Cervical HPV infection and cervical/vulvovaginal disease in women participating in AMC clinical trials

    Baseline, every 6 months while on parent protocol, treatment discontinuation on parent protocol, final visit on parent protocol

  • Changes in cervical HPV infection and cervical/vulvovaginal disease after treatment on AMC studies

    Baseline, every 6 months while on parent protocol, treatment discontinuation on parent protocol, final visit on parent protocol

  • Changes in anal HPV types present

    Baseline, every 6 months while on parent protocol, treatment discontinuation on parent protocol, final visit on parent protocol

  • Frequency of ASIL

    Baseline, treatment discontinuation on parent protocol, final visit on parent protocol

Study Arms (1)

Specimen Collection

Blood collection, anal cytology and biopsy of observed lesions. Additional cervical cytology and biopsy for females.

Genetic: polymerase chain reactionOther: cytology specimen collection procedureOther: histological techniqueProcedure: colposcopic biopsy

Interventions

polymerase chain reactionGENETIC

PCR for HPV DNA detection, performed on specimens collected at baseline, every 6 months while on parent protocol, treatment discontinuation on parent protocol, final visit on parent protocol.

Specimen Collection
cytology specimen collection procedureOTHER

Detection of HPV-associated neoplasia at baseline, every 6 months while on parent protocol, treatment discontinuation on parent protocol, final visit on parent protocol.

Specimen Collection
histological techniqueOTHER

Detection of HPV-associated neoplasia at baseline, treatment discontinuation on parent protocol, final visit on parent protocol.

Specimen Collection
colposcopic biopsyPROCEDURE

Where observed during HRA, collection of tissue for detection of HPV-associated neoplasia at baseline, treatment discontinuation on parent protocol, final visit on parent protocol.

Specimen Collection

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

This study will enroll patients who are study participants on interventional AMC protocols for diseases other than HPV-associated neoplasia with an accrual goal of 15 patients or more.

DISEASE CHARACTERISTICS: * 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 PATIENT CHARACTERISTICS: * 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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (10)

Rebecca and John Moores UCSD Cancer Center

La Jolla, California, 92093-0658, United States

Location

USC/Norris Comprehensive Cancer Center and Hospital

Los Angeles, California, 90089-9181, United States

Location

UCLA Clinical AIDS Research and Education (CARE) Center

Los Angeles, California, 90095-1793, United States

Location

UCSF Helen Diller Family Comprehensive Cancer Center

San Francisco, California, 94115, United States

Location

Cancer Research Center of Hawaii

Honolulu, Hawaii, 96813, United States

Location

Boston University Cancer Research Center

Boston, Massachusetts, 02118, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

Memorial Sloan-Kettering Cancer Center

New York, New York, 10065, United States

Location

Baylor University Medical Center - Houston

Houston, Texas, 77030-2707, United States

Location

Benaroya Research Institute at Virginia Mason Medical Center

Seattle, Washington, 98101, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood specimens, anal cytology and biopsy of any lesions observed, cervical cytology and biopsy of any lesions observed.

MeSH Terms

Conditions

LymphomaPrecancerous ConditionsSarcomaSquamous Intraepithelial LesionsPapillomavirus InfectionsAIDS-related Kaposi sarcomaMulti-centric Castleman's DiseaseHIV Infections

Interventions

Polymerase Chain ReactionHistological Techniques

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesNeoplasms, Connective and Soft TissueMorphological and Microscopic FindingsPathological Conditions, Signs and SymptomsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesCommunicable DiseasesInfectionsDNA Virus InfectionsVirus DiseasesTumor Virus InfectionsGenital DiseasesUrogenital DiseasesDisease AttributesPathologic ProcessesBlood-Borne InfectionsLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsImmunologic Deficiency Syndromes

Intervention Hierarchy (Ancestors)

Nucleic Acid Amplification TechniquesGenetic TechniquesInvestigative TechniquesClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosis

Study Officials

  • J. Michael Berry, MD

    University of California, San Francisco

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 7, 2008

First Posted

June 11, 2008

Study Start

May 14, 2008

Primary Completion

April 19, 2017

Study Completion

April 19, 2017

Last Updated

August 10, 2020

Record last verified: 2020-08

Data Sharing

IPD Sharing
Will not share

Locations

US(10)