Aids-related MalignanciesNCT00695422
Detecting Anal and Genital Human Papillomavirus Infection and Squamous Intraepithelial Lesions in HIV-Positive Patients Enrolled in AIDS Cancer Clinical Trials
An observational study of Aids-related Malignancies and Lymphoma, run by AIDS Malignancy Consortium at 10 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aids-related Malignancies, Lymphoma, Precancerous Condition
- What is being tested?
- polymerase chain reaction, cytology specimen collection procedure and histological technique
- Type of treatment
- Surgery or procedure
- How many people
- 47 participants
- Where
- 10 sitesUnited States
- Study dates
- 14 May 2008to 19 Apr 2017
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
Boston University Cancer Research Center
Boston, Massachusetts, 02118
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
Cancer Research Center of Hawaii
Honolulu, Hawaii, 96813
Baylor University Medical Center - Houston
Houston, Texas, 77030-2707
Rebecca and John Moores UCSD Cancer Center
La Jolla, California, 92093-0658
USC/Norris Comprehensive Cancer Center and Hospital
Los Angeles, California, 90089-9181
UCLA Clinical AIDS Research and Education (CARE) Center
Los Angeles, California, 90095-1793
Memorial Sloan-Kettering Cancer Center
New York, New York, 10065
UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco, California, 94115
Benaroya Research Institute at Virginia Mason Medical Center
Seattle, Washington, 98101
About this study
Official title: A Companion Protocol to Evaluate Anogenital Human Papillomavirus (HPV) Infection and Anogenital Squamous Intraepithelial Lesions (ASIL) in Subjects Participating in AMC Clinical Trials
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.
Read the detailed description
OBJECTIVES:
Primary
- 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.
- Conditions
- Aids-related Malignancies, Lymphoma, Precancerous Condition, Sarcoma
- Being tested
- polymerase chain reaction, cytology specimen collection procedure, histological technique, colposcopic biopsy
- Keywords
- high-grade squamous intraepithelial lesion, low-grade squamous intraepithelial lesion, human papilloma virus infection, AIDS-related diffuse large cell lymphoma, AIDS-related diffuse mixed cell lymphoma, AIDS-related diffuse small cleaved cell lymphoma, AIDS-related immunoblastic large cell lymphoma, AIDS-related Kaposi sarcoma, AIDS-related lymphoblastic lymphoma, AIDS-related malignancies, AIDS-related peripheral/systemic lymphoma, AIDS-related primary CNS lymphoma, AIDS-related small noncleaved cell lymphoma, multicentric Castleman disease, HIV Infections
- Medical subject headings
- Lymphoma, Precancerous Conditions, Sarcoma, Squamous Intraepithelial Lesions, Papillomavirus Infections, AIDS-related Kaposi sarcoma, Multi-centric Castleman's Disease, HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
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.
histological techniqueOther
Detection of HPV-associated neoplasia at baseline, treatment discontinuation on parent protocol, final visit on parent protocol.
colposcopic biopsyProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Specimen Collection | Blood collection, anal cytology and biopsy of observed lesions. Additional cervical cytology and biopsy for females. Receives: Genetic: polymerase chain reaction; Other: cytology specimen collection procedure; Other: histological technique; Procedure: colposcopic biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Activity of pharmacotherapeutic agents being investigated in AIDS Malignancy Clinical Trials (AMC) against anogenital human papillomavirus (HPV) infection or anogenital squamous intraepithelial lesions (ASIL)
Measured: 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
Measured: 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
Measured: Baseline, every 6 months while on parent protocol, treatment discontinuation on parent protocol, final visit on parent protocol
Changes in anal HPV types present
Measured: Baseline, every 6 months while on parent protocol, treatment discontinuation on parent protocol, final visit on parent protocol
Frequency of ASIL
Measured: Baseline, treatment discontinuation on parent protocol, final visit on parent protocol
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2008 (estimated)
- Study start14 May 2008
- Primary completion19 Apr 2017
- Study completion19 Apr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aids-related MalignanciesStudies of the same condition, open and under way.
- 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
- Prospective
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- AIDS Malignancy Consortium
- Sponsor type
- Research network
- Collaborators
- National Cancer Institute (NCI), The Emmes Company, LLC
- Responsible party
- Sponsor
- Investigators
- J. Michael Berry, MD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00695422
- Sponsor's protocol ID
- AMC-058
- Other IDs
- U01CA121947, CDR0000590397
- Status last verified
- Aug 2020
- First submitted
- 7 Jun 2008
- Last updated
- 10 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Companion Protocol to Evaluate Anogenital Human Papillomavirus (HPV) Infection and Anogenital Squamous Intraepithelial Lesions (ASIL) in Subjects Participating in AMC Clinical Trials
- ClinicalTrials.gov ID
- NCT00695422
- Acronym / sponsor ID
- AMC-058
- Conditions
- Aids-related Malignancies, Lymphoma, Precancerous Condition, Sarcoma
- Keywords
- high-grade squamous intraepithelial lesion, low-grade squamous intraepithelial lesion, human papilloma virus infection, AIDS-related diffuse large cell lymphoma, AIDS-related diffuse mixed cell lymphoma, AIDS-related diffuse small cleaved cell lymphoma, AIDS-related immunoblastic large cell lymphoma, AIDS-related Kaposi sarcoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- AIDS Malignancy ConsortiumResearch network
- Collaborators
- National Cancer Institute (NCI), The Emmes Company, LLC
- Study start
- 14 May 2008 (actual)
- Primary completion
- 19 Apr 2017 (actual)
- Study completion
- 19 Apr 2017 (actual)
- First posted
- 11 Jun 2008 (estimated)
- 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.
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.
Detailed description
OBJECTIVES:
Primary
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Specimen Collection | – | Genetic: polymerase chain reaction, Other: cytology specimen collection procedure, Other: histological technique, Procedure: colposcopic biopsyBlood collection, anal cytology and biopsy of observed lesions. Additional cervical cytology and biopsy for females. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
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 |
|---|---|---|
| polymerase chain reactionPCR 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. | Genetic | Specimen Collection |
| cytology specimen collection procedureDetection of HPV-associated neoplasia at baseline, every 6 months while on parent protocol, treatment discontinuation on parent protocol, final visit on parent protocol. | Other | Specimen Collection |
| histological techniqueDetection of HPV-associated neoplasia at baseline, treatment discontinuation on parent protocol, final visit on parent protocol. | Other | Specimen Collection |
| colposcopic biopsyWhere observed during HRA, collection of tissue for detection of HPV-associated neoplasia at baseline, treatment discontinuation on parent protocol, final visit on parent protocol. | Procedure or surgery | Specimen Collection |
Primary outcome
Activity of pharmacotherapeutic agents being investigated in AIDS Malignancy Clinical Trials (AMC) against anogenital human papillomavirus (HPV) infection or anogenital squamous intraepithelial lesions (ASIL)
Time frame: 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
Time frame: 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
Time frame: Baseline, every 6 months while on parent protocol, treatment discontinuation on parent protocol, final visit on parent protocol
Changes in anal HPV types present
Time frame: Baseline, every 6 months while on parent protocol, treatment discontinuation on parent protocol, final visit on parent protocol
Frequency of ASIL
Time frame: Baseline, treatment discontinuation on parent protocol, final visit on parent protocol
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 10 Aug 2020.
- Individual participant dataSharing planned: No
Related trials for Aids-related Malignancies
RecruitingPhase 1
AMC 120, Glofitamab Plus Chemoimmunotherapy in Newly Diagnosed HIV-Associated Large B-Cell Lymphoma (The "Glofit-RCHOP Study")
AIDS-Related Diffuse Large B-cell Lymphoma, Diffuse Large B-Cell Lymphoma, Not Otherwise Specified
RecruitingPhase 2
CASCADE 2002: PROTECT Study, "PRObiotics to TrEat Anal preCancer Trial
HSIL, High Grade Squamous Intraepithelial Lesion, HPV-Related Squamous Cell Carcinoma
Active, not recruitingPhase 1/2
Lenalidomide Combined With Modified DA-EPOCH and Rituximab (EPOCH-R2) in Primary Effusion Lymphoma or KSHV-associated Large Cell Lymphoma
Primary Effusion Lymphoma, B-Cell Neoplasm
RecruitingObservational study
Specimen Collections From Participants With HIV Infection, KSHV Infection, Viral-Related Pre-malignant Lesions and Cancer
HIV, Kaposi's Sarcoma
Not yet recruiting
Improving Clinic Delivery of HIV-related Anal Health Services
HIV, Gonorrhea
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.
J. Michael Berry, MD principal investigator
University of California, San Francisco
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aids-related Malignancies and Lymphoma, run by AIDS Malignancy Consortium at 10 sites 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?
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 10 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites 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?
Activity of pharmacotherapeutic agents being investigated in AIDS Malignancy Clinical Trials (AMC) against anogenital human papillomavirus (HPV) infection or anogenital squamous intraepithelial lesions (ASIL) (time frame: Baseline, every 6 months while on parent protocol, treatment discontinuation on parent protocol, final visit on parent protocol). The study lists 5 primary outcomes in all. 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 10 Aug 2020.