Lung Cancer, Lymphoma
Conditions
Keywords
HIV infection, adult diffuse large cell lymphoma, non-small cell lung cancer, AIDS-related diffuse large cell lymphoma
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.
Interventions
GENETICDNA analysis
This sample will be used for germline DNA analysis.
GENETICRNA analysis
RNA will be sheared, reverse transcribed, and sequenced to assess transcribed sequences.
GENETICgene expression analysis
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.
GENETICpolymorphism analysis
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.
OTHERbiologic sample preservation procedure
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.
OTHERflow cytometry
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.
OTHERmedical chart review
Participants will be followed prospectively to record the types of treatment given, and treatment outcome and toxicity.
Sponsors
National Cancer Institute (NCI)
The Emmes Company, LLC
AIDS and Cancer Specimen Resource
University of Arkansas
AIDS Malignancy Consortium
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Collection of Tissue Specimen From Study Participants | Study entry (prior to chemotherapy initiation) | Summary of the specimens available by study arm |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| HIV-positive Diffuse Large B-cell Lymphoma Cases Tissue collection for genomic sequencing from persons with a diagnosis of HIV and diffuse large B-cell lymphoma. | 93 |
| HIV-positive Lung Cancer Cases Tissue collection for genomic sequencing from persons with a diagnosis of HIV and lung cancer. | 19 |
| HIV Positive Cervical Cancer Cases Tissue collection for genomic sequencing from persons with a diagnosis of HIV and cervical cancer. | 2 |
| Total | 114 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Insufficient tissue available to satisfy the protocol requirements | 2 | 0 | 0 |
| Overall Study | Not being able to get tissue for Central Pathology Review prior to the protocol closure date | 1 | 0 | 0 |
| Overall Study | Not enough tissue left for the tissue scrolls | 1 | 0 | 0 |
| Overall Study | Protocol closure by the OCG | 2 | 0 | 0 |
Baseline characteristics
| Characteristic | HIV-positive Diffuse Large B-cell Lymphoma Cases | HIV-positive Lung Cancer Cases | HIV Positive Cervical Cancer Cases | Total |
|---|---|---|---|---|
| Age, Continuous | 50.10 years STANDARD_DEVIATION 10.86 | 61.42 years STANDARD_DEVIATION 6.22 | 49.50 years STANDARD_DEVIATION 7.78 | 51.97 years STANDARD_DEVIATION 10.99 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 27 Participants | 3 Participants | 0 Participants | 30 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 60 Participants | 16 Participants | 2 Participants | 78 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 6 Participants | 0 Participants | 0 Participants | 6 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 32 Participants | 10 Participants | 2 Participants | 44 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 10 Participants | 3 Participants | 0 Participants | 13 Participants |
| Race (NIH/OMB) White | 51 Participants | 6 Participants | 0 Participants | 57 Participants |
| Sex: Female, Male Female | 11 Participants | 8 Participants | 2 Participants | 21 Participants |
| Sex: Female, Male Male | 82 Participants | 11 Participants | 0 Participants | 93 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 0 | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 | 0 / 0 |
Outcome results
Primary
Collection of Tissue Specimen From Study Participants
Summary of the specimens available by study arm
Time frame: Study entry (prior to chemotherapy initiation)
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| HIV-positive Diffuse Large B-cell Lymphoma Cases | Collection of Tissue Specimen From Study Participants | Hematoxylin and eosin stained slide | 8 Participants |
| HIV-positive Diffuse Large B-cell Lymphoma Cases | Collection of Tissue Specimen From Study Participants | Formalin-fixed, paraffin-embedded for genomic sequence analysis | 13 Participants |
| HIV-positive Diffuse Large B-cell Lymphoma Cases | Collection of Tissue Specimen From Study Participants | Peripheral Blood Mononuclear Cells | 68 Participants |
| HIV-positive Diffuse Large B-cell Lymphoma Cases | Collection of Tissue Specimen From Study Participants | Central pathology review | 85 Participants |
| HIV-positive Diffuse Large B-cell Lymphoma Cases | Collection of Tissue Specimen From Study Participants | Tissue core | 3 Participants |
| HIV-positive Diffuse Large B-cell Lymphoma Cases | Collection of Tissue Specimen From Study Participants | Formalin-fixed, paraffin-embedded tissue block for cental pathology review | 39 Participants |
| HIV-positive Diffuse Large B-cell Lymphoma Cases | Collection of Tissue Specimen From Study Participants | Tissue scroll | 9 Participants |
| HIV-positive Diffuse Large B-cell Lymphoma Cases | Collection of Tissue Specimen From Study Participants | Unstained slide from tissue | 65 Participants |
| HIV-positive Diffuse Large B-cell Lymphoma Cases | Collection of Tissue Specimen From Study Participants | Specimen for Genomic sequence analysis | 71 Participants |
| HIV-positive Diffuse Large B-cell Lymphoma Cases | Collection of Tissue Specimen From Study Participants | Snap frozen biopsy | 4 Participants |
| HIV-positive Lung Cancer Cases | Collection of Tissue Specimen From Study Participants | Tissue scroll | 3 Participants |
| HIV-positive Lung Cancer Cases | Collection of Tissue Specimen From Study Participants | Formalin-fixed, paraffin-embedded tissue block for cental pathology review | 7 Participants |
| HIV-positive Lung Cancer Cases | Collection of Tissue Specimen From Study Participants | Hematoxylin and eosin stained slide | 3 Participants |
| HIV-positive Lung Cancer Cases | Collection of Tissue Specimen From Study Participants | Peripheral Blood Mononuclear Cells | 14 Participants |
| HIV-positive Lung Cancer Cases | Collection of Tissue Specimen From Study Participants | Specimen for Genomic sequence analysis | 16 Participants |
| HIV-positive Lung Cancer Cases | Collection of Tissue Specimen From Study Participants | Unstained slide from tissue | 12 Participants |
| HIV-positive Lung Cancer Cases | Collection of Tissue Specimen From Study Participants | Tissue core | 3 Participants |
| HIV-positive Lung Cancer Cases | Collection of Tissue Specimen From Study Participants | Central pathology review | 18 Participants |
| HIV-positive Lung Cancer Cases | Collection of Tissue Specimen From Study Participants | Formalin-fixed, paraffin-embedded for genomic sequence analysis | 5 Participants |
| HIV-positive Lung Cancer Cases | Collection of Tissue Specimen From Study Participants | Snap frozen biopsy | 1 Participants |
| HIV Positive Cervical Cancer Cases | Collection of Tissue Specimen From Study Participants | Formalin-fixed, paraffin-embedded for genomic sequence analysis | 0 Participants |
| HIV Positive Cervical Cancer Cases | Collection of Tissue Specimen From Study Participants | Tissue scroll | 1 Participants |
| HIV Positive Cervical Cancer Cases | Collection of Tissue Specimen From Study Participants | Central pathology review | 2 Participants |
| HIV Positive Cervical Cancer Cases | Collection of Tissue Specimen From Study Participants | Formalin-fixed, paraffin-embedded tissue block for cental pathology review | 0 Participants |
| HIV Positive Cervical Cancer Cases | Collection of Tissue Specimen From Study Participants | Unstained slide from tissue | 2 Participants |
| HIV Positive Cervical Cancer Cases | Collection of Tissue Specimen From Study Participants | Snap frozen biopsy | 0 Participants |
| HIV Positive Cervical Cancer Cases | Collection of Tissue Specimen From Study Participants | Hematoxylin and eosin stained slide | 1 Participants |
| HIV Positive Cervical Cancer Cases | Collection of Tissue Specimen From Study Participants | Peripheral Blood Mononuclear Cells | 1 Participants |
| HIV Positive Cervical Cancer Cases | Collection of Tissue Specimen From Study Participants | Tissue core | 0 Participants |
| HIV Positive Cervical Cancer Cases | Collection of Tissue Specimen From Study Participants | Specimen for Genomic sequence analysis | 2 Participants |