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| ID | Type | Description | Link |
|---|---|---|---|
| CDR0000729843 | Other Identifier | NCI | |
| U01CA121947 | U.S. NIH Grant/Contract | View source |
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Sponsor directive
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
| The Emmes Company, LLC | INDUSTRY |
| AIDS and Cancer Specimen Resource | OTHER |
| University of Arkansas |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
| |
| HIV-positive lung cancer cases | Tissue collection for genomic sequencing from persons with a diagnosis of HIV and lung cancer. |
| |
| HIV-positive cervical cancer cases | Tissue specimen collection from HIV positive patients with a diagnosis of cervical cancer |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DNA analysis | Genetic | This sample will be used for germline DNA analysis. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Collection of Tissue Specimen From Study Participants | Summary of the specimens available by study arm | Study entry (prior to chemotherapy initiation) |
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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:
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:
PRIOR CONCURRENT THERAPY:
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HIV-infected males and females age 18 and older with one of the three malignancy types studied with available diagnostic biopsy material
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| Name | Affiliation | Role |
|---|---|---|
| Lee Ratner, MD, PhD | Washington University Siteman Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Moores UCSD Cancer Center | La Jolla | California | 92093-0658 | United States | ||
| UCLA Clinical AIDS Research and Education (CARE) Center |
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| Label | URL |
|---|---|
| Clinicaltrials.gov summary of trial | View source |
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Results will be submitted to dBGaP
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | HIV-positive Lung Cancer Cases |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 25, 2020 |
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| OTHER |
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Fresh-frozen tissue, peripheral blood mononuclear cells, formalin-fixed, paraffin-embedded tissue
| RNA analysis | Genetic | RNA will be sheared, reverse transcribed, and sequenced to assess transcribed sequences. |
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| gene expression analysis | Genetic | 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. |
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| polymorphism analysis | Genetic | 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. |
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| biologic sample preservation procedure | Other | 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. |
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| flow cytometry | Other | 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. |
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| medical chart review | Other | Participants will be followed prospectively to record the types of treatment given, and treatment outcome and toxicity. |
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| Los Angeles |
| California |
| 90095-1793 |
| United States |
| George Washington University | Washington D.C. | District of Columbia | 20052 | United States |
| University of Miami | Miami | Florida | 33136 | United States |
| John H. Stroger Hospital of Cook County | Chicago | Illinois | 60612 | United States |
| Louisiana State University Public Hospital | New Orleans | Louisiana | 70112 | United States |
| Washington University School of Medicine | St Louis | Missouri | 63110 | United States |
| Memorial Sloan Kettering Cancer Center | New York | New York | 10021 | United States |
| Albert Einstein Cancer Center at Albert Einstein College of Medicine | The Bronx | New York | 10461 | United States |
| UNC Lineberger Comprehensive Cancer Center | Chapel Hill | North Carolina | 27599 | United States |
| University of Pennsylvania - Abramson Cancer Center at Pennsylvania Hospital | Philadelphia | Pennsylvania | 19106 | United States |
| Fox Chase Cancer Center | Philadelphia | Pennsylvania | 19111 | United States |
| Harborview Madison Clinic | Seattle | Washington | 98104 | United States |
| Virginia Mason Medical Center | Seattle | Washington | 98111 | United States |
Tissue collection for genomic sequencing from persons with a diagnosis of HIV and lung cancer.
| FG002 | Cervical Cancer | Tissue collection for genomic sequencing from persons with a diagnosis of HIV and cervical cancer. |
| COMPLETED |
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| NOT COMPLETED |
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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.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | HIV-positive Lung Cancer Cases | Tissue collection for genomic sequencing from persons with a diagnosis of HIV and lung cancer. |
| BG002 | HIV Positive Cervical Cancer Cases | Tissue collection for genomic sequencing from persons with a diagnosis of HIV and cervical cancer. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Collection of Tissue Specimen From Study Participants | Summary of the specimens available by study arm | Posted | Count of Participants | Participants | Study entry (prior to chemotherapy initiation) |
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Adverse events data was not collected for this study..
As a laboratory study involving only sample collection through routine clinical care and data abstraction, no adverse events was collected for this study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. | 0 | 0 | 0 | 0 | 0 | 0 |
| EG001 | HIV-positive Lung Cancer Cases | Tissue collection for genomic sequencing from persons with a diagnosis of HIV and lung cancer. | 0 | 0 | 0 | 0 | 0 | 0 |
| EG002 | HIV Positive Cervical Cancer Cases | Tissue collection for genomic sequencing from persons with a diagnosis of HIV and cervical cancer. | 0 | 0 | 0 | 0 | 0 | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Madhu Mazumdar | AMC Statistical Center | (212) 659-9558 | madhu.mazumdar@mountsinai.org |
| Feb 15, 2023 |
| Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Nov 18, 2020 | Feb 15, 2023 | ICF_001.pdf |
| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| D008223 | Lymphoma |
| D015658 | HIV Infections |
| D016403 | Lymphoma, Large B-Cell, Diffuse |
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D009370 | Neoplasms by Histologic Type |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D016393 | Lymphoma, B-Cell |
| D008228 | Lymphoma, Non-Hodgkin |
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
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| ID | Term |
|---|---|
| D020869 | Gene Expression Profiling |
| D054458 | Amplified Fragment Length Polymorphism Analysis |
| D005434 | Flow Cytometry |
| ID | Term |
|---|---|
| D005821 | Genetic Techniques |
| D008919 | Investigative Techniques |
| D016172 | DNA Fingerprinting |
| D016133 | Polymerase Chain Reaction |
| D021141 | Nucleic Acid Amplification Techniques |
| D002469 | Cell Separation |
| D003584 | Cytological Techniques |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D003592 | Cytophotometry |
| D005470 | Fluorometry |
| D008163 | Luminescent Measurements |
| D010783 | Photometry |
| D002623 | Chemistry Techniques, Analytical |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Unstained slide from tissue |
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| Specimen for Genomic sequence analysis |
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| Snap frozen biopsy |
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| Hematoxylin and eosin stained slide |
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| Peripheral Blood Mononuclear Cells |
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| Tissue core |
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| Tissue scroll |
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| Formalin-fixed, paraffin-embedded for genomic sequence analysis |
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