NCT01567722 · REGISTRY CONDITION SEARCH

Collecting and Studying Tissue Samples From Patients With HIV-Associated Malignancies

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase: Not reported
Status at capture: TERMINATED
Registry last update: 2023-03-16

RATIONALE: Collecting and studying tissue samples from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. PURPOSE: This research trial studies collecting tissue samples from patients with HIV-related malignancies.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Collection of Tissue Specimen From Study Participants

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part

eligibility Criteria: DISEASE CHARACTERISTICS: * Participants must have a diagnosis of a malignancy or clinical findings suggestive of a possible HIV-associated malignancy of one of three types: * Diffuse large B-cell lymphoma * Non-small cell lung malignancy * The presence of any of the following conditions will exclude a participant from study enrollment: * Absence of sufficient diagnostic tumor-biopsy tissue material to meet the protocol requirements for baseline specimen submission (minimum specimen size of 10 x 10 x 2 mm); repeat tumor biopsy will not be performed solely to meet the protocol specimen-collection requirements * Participants whose biopsies, for the purpose of this protocol, show a diagnosis of anal intraepithelial neoplasia or cervical intraepithelial neoplasia * Prior treatment for the study malignancy (including neo-adjuvants), since treatment can affect the mutational spectra of tumors * HIV infection based on serologic documentation of HIV infection at any time prior to study entry, as evidenced by positive enzyme-linked immunosorbent assay (ELISA), positive western blot, or any other Food and Drug Administration (FDA)-approved (licensed) HIV test; alternatively, this documentation may include a record that another physician has documented that the patient has HIV based on prior ELISA and western blot, or other approved diagnostic tests PATIENT CHARACTERISTICS: * Participants must be willing and able to sign an IRB-approved informed consent document PRIOR CONCURRENT THERAPY: * See Disease Characteristics
healthy Volunteers: false
minimum Age: 18 Years
sampling Method: NON_PROBABILITY_SAMPLE
sex: ALL
std Ages: ADULT
OLDER_ADULT
study Population: HIV-infected males and females age 18 and older with one of the three malignancy types studied with available diagnostic biopsy material

Treatment arms and interventions

arm Groups

description
Tissue collection for genomic sequencing from persons with a diagnosis of HIV and diffuse large B-cell lymphoma.
intervention Names
Genetic: DNA analysis
Genetic: RNA analysis
Genetic: gene expression analysis
Genetic: polymorphism analysis
Other: biologic sample preservation procedure
Other: flow cytometry
Other: medical chart review
label
HIV-positive diffuse large B-cell lymphoma cases
description
Tissue collection for genomic sequencing from persons with a diagnosis of HIV and lung cancer.
intervention Names
Genetic: DNA analysis
Genetic: RNA analysis
Genetic: gene expression analysis
Genetic: polymorphism analysis
Other: biologic sample preservation procedure
Other: flow cytometry
Other: medical chart review
label
HIV-positive lung cancer cases
description
Tissue specimen collection from HIV positive patients with a diagnosis of cervical cancer
label
HIV-positive cervical cancer cases

interventions

arm Group Labels
HIV-positive diffuse large B-cell lymphoma cases
HIV-positive lung cancer cases
description
This sample will be used for germline DNA analysis.
name
DNA analysis
type
GENETIC
arm Group Labels
HIV-positive diffuse large B-cell lymphoma cases
HIV-positive lung cancer cases
description
RNA will be sheared, reverse transcribed, and sequenced to assess transcribed sequences.
name
RNA analysis
type
GENETIC
arm Group Labels
HIV-positive diffuse large B-cell lymphoma cases
HIV-positive lung cancer cases
description
Genomic analyses performed on these samples may include, but are not limited to, array-based gene expression profiling, comparative genome hybridization, and single nucleotide polymorphism studies, as well as whole genome sequencing analysis using the most current genomic technology available.
name
gene expression analysis
type
GENETIC
arm Group Labels
HIV-positive diffuse large B-cell lymphoma cases
HIV-positive lung cancer cases
description
Genomic analyses performed on these samples may include, but are not limited to, array-based gene expression profiling, comparative genome hybridization, and single nucleotide polymorphism studies, as well as whole genome sequencing analysis using the most current genomic technology available.
name
polymorphism analysis
type
GENETIC
arm Group Labels
HIV-positive diffuse large B-cell lymphoma cases
HIV-positive lung cancer cases
description
Genomic analyses performed on these samples may include, but are not limited to, array-based gene expression profiling, comparative genome hybridization, and single nucleotide polymorphism studies, as well as whole genome sequencing analysis using the most current genomic technology available.
name
biologic sample preservation procedure
type
OTHER
arm Group Labels
HIV-positive diffuse large B-cell lymphoma cases
HIV-positive lung cancer cases
description
Information will include HIV RNA load at time of malignancy diagnosis) and imaging tests, results of the diagnostic tumor biopsy and bone marrow biopsy, and results of flow cytometry, cytogenetics, and molecular studies.
name
flow cytometry
type
OTHER
arm Group Labels
HIV-positive diffuse large B-cell lymphoma cases
HIV-positive lung cancer cases
description
Participants will be followed prospectively to record the types of treatment given, and treatment outcome and toxicity.
name
medical chart review
type
OTHER

Study design

observational Model: CASE_ONLY
time Perspective: PROSPECTIVE

Enrollment

count: 114
type: ACTUAL

Registered outcome plans (not posted results)

primary Outcomes

description
Summary of the specimens available by study arm
measure
Collection of Tissue Specimen From Study Participants
time Frame
Study entry (prior to chemotherapy initiation)

Full study description

brief Summary: RATIONALE: Collecting and studying tissue samples from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. PURPOSE: This research trial studies collecting tissue samples from patients with HIV-related malignancies.
detailed Description: OBJECTIVES: * To obtain high-quality, clinically annotated tissue from patients with human immunodeficiency virus (HIV)-1 malignancy. * To study clinical, genetic, and immunologic parameters that have prognostic significance and/or are involved in the initiation and progression of HIV-1 malignancies, including complete genomic sequence determination of HIV-associated diffuse large B-cell lymphomas, lung cancer, anal cancer, and cervical cancer. OUTLINE: This is a multicenter study. Patients undergo tumor, lymph node, bone marrow, or skin biopsy, and peripheral blood mononuclear cells collection. Samples are submitted to the AIDS Malignancy Consortium (AMC) Biorepository and transferred to the AIDS and Cancer Specimen Resource (ACSR). Samples are then analyzed by the Genome Science Center of British Columbia (GSC-BC) and the HIV+ Tumor Molecular Characterization Project (HTMCP) for full genomic sequencing analysis that may include, but are not limited to, array-based gene expression profiling, comparative genome hybridization, and single nucleotide polymorphism studies by flow cytometry, cytogenetics, and molecular studies. Patients' clinical data, demographics, and treatment given are also collected prospectively in order to record treatment outcome and toxicity. Patients are followed up at 6 months, 1 year, and 2 years for data-reporting purposes.

Source references