An observational study in Lung Cancer and Lymphoma, sponsored by AIDS Malignancy Consortium. Terminated at 14 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-03-16.
Sponsored by AIDS Malignancy Consortium · Observational
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.
OBJECTIVES:
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.
5,578 studies on the registry are indexed under Lymphoma; 825 are open to participants now.
This study's enrollment of 114 is below the median of 136 across 625 observational studies indexed under Lymphoma.
Browse Lymphoma studies →AIDS Malignancy Consortium is the lead sponsor of 61 studies on the registry; 10 are open to participants now.
Of its 10 completed or terminated interventional studies of FDA-regulated products, 8 (80%) have results posted.
Counted across the registry records on this site, refreshed daily.
HIV-infected males and females age 18 and older with one of the three malignancy types studied with available diagnostic biopsy material
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:
The presence of any of the following conditions will exclude a participant from study enrollment:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
Tissue collection for genomic sequencing from persons with a diagnosis of HIV and diffuse large B-cell lymphoma.
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
Tissue collection for genomic sequencing from persons with a diagnosis of HIV and lung cancer.
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
Tissue specimen collection from HIV positive patients with a diagnosis of cervical cancer
This sample will be used for germline DNA analysis.
RNA will be sheared, reverse transcribed, and sequenced to assess transcribed sequences.
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.
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.
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.
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.
Participants will be followed prospectively to record the types of treatment given, and treatment outcome and toxicity.
Collection of Tissue Specimen From Study Participants
Summary of the specimens available by study arm
Time frame: Study entry (prior to chemotherapy initiation)
| Milestone | HIV-positive Diffuse Large B-cell Lymphoma Cases | HIV-positive Lung Cancer Cases | Cervical Cancer |
|---|---|---|---|
| Started | 93 | 19 | 2 |
| Completed | 87 | 19 | 2 |
| Not completed | 6 | 0 | 0 |
| Withdrew: Not being able to get tissue for central pathology review prior to the protocol closure date | 1 | 0 | 0 |
| Withdrew: Insufficient tissue available to satisfy the protocol requirements | 2 | 0 | 0 |
| Withdrew: Protocol closure by the ocg | 2 | 0 | 0 |
| Withdrew: Not enough tissue left for the tissue scrolls | 1 | 0 | 0 |
Summary of the specimens available by study arm
| Participants | HIV-positive Diffuse Large B-cell Lymphoma Cases | HIV-positive Lung Cancer Cases | HIV Positive Cervical Cancer Cases |
|---|---|---|---|
| Central pathology review | 85 | 18 | 2 |
| Formalin-fixed, paraffin-embedded tissue block for cental pathology review | 39 | 7 | 0 |
| Unstained slide from tissue | 65 | 12 | 2 |
| Specimen for Genomic sequence analysis | 71 | 16 | 2 |
| Snap frozen biopsy | 4 | 1 | 0 |
| Hematoxylin and eosin stained slide | 8 | 3 | 1 |
| Peripheral Blood Mononuclear Cells | 68 | 14 | 1 |
| Tissue core | 3 | 3 | 0 |
| Tissue scroll | 9 | 3 | 1 |
| Formalin-fixed, paraffin-embedded for genomic sequence analysis | 13 | 5 | 0 |
Collected over Adverse events data was not collected for this study... Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| HIV-positive Diffuse Large B-cell Lymphoma Cases | — | — | — |
| HIV-positive Lung Cancer Cases | — | — | — |
| HIV Positive Cervical Cancer Cases | — | — | — |
HIV-positive persons age 18 and older with a diagnosis of a malignancy limited to the following diagnoses: any variant of diffuse large B cell lymphoma (DLBCL) except Burkitt's lymphoma, non-small cell lung malignancy or cervical cancer.
| Age, Continuous(years) | HIV-positive Diffuse Large B-cell Lymphoma Cases | HIV-positive Lung Cancer Cases | HIV Positive Cervical Cancer Cases | Total |
|---|---|---|---|---|
| Mean | 50.10 ± 10.86 | 61.42 ± 6.22 | 49.50 ± 7.78 | 51.97 ± 10.99 |
| Sex: Female, Male(Participants) | HIV-positive Diffuse Large B-cell Lymphoma Cases | HIV-positive Lung Cancer Cases | HIV Positive Cervical Cancer Cases | Total |
|---|---|---|---|---|
| Female | 11 | 8 | 2 | 21 |
| Male | 82 | 11 | 0 | 93 |
| Ethnicity (NIH/OMB)(Participants) | HIV-positive Diffuse Large B-cell Lymphoma Cases | HIV-positive Lung Cancer Cases | HIV Positive Cervical Cancer Cases | Total |
|---|---|---|---|---|
| Hispanic or Latino | 27 | 3 | 0 | 30 |
| Not Hispanic or Latino | 60 | 16 | 2 | 78 |
| Unknown or Not Reported | 6 | 0 | 0 | 6 |
| Race (NIH/OMB)(Participants) | HIV-positive Diffuse Large B-cell Lymphoma Cases | HIV-positive Lung Cancer Cases | HIV Positive Cervical Cancer Cases | Total |
|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 |
| Black or African American | 32 | 10 | 2 | 44 |
| White | 51 | 6 | 0 | 57 |
| More than one race | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 10 | 3 | 0 | 13 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — Results will be submitted to dBGaP
This study is terminated, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
AIDS Malignancy Consortium