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.
PURPOSE: This research trial studies collecting tissue samples from patients with HIV-related malignancies.
Brief Title
Collecting and Studying Tissue Samples From Patients With HIV-Associated 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.
* 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.
Categories
Completion Date
Completion Date Type
Actual
Conditions
Lung Cancer
Lymphoma
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
* 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
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
* 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
Gender
All
Gender Based
false
Keywords
HIV infection
adult diffuse large cell lymphoma
non-small cell lung cancer
AIDS-related diffuse large cell lymphoma
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Minimum Age
18 Years
NCT Id
NCT01567722
Org Class
Network
Org Full Name
AIDS Malignancy Consortium
Org Study Id
AMC-083
Overall Status
Terminated
Primary Completion Date
Primary Completion Date Type
Actual
Official Title
Tissue Acquisition for Analysis of Prognostic Factors, Immunology, and Genetic Progression of HIV-1 Associated Malignancies
Primary Outcomes
Outcome Description
Summary of the specimens available by study arm
Outcome Measure
Collection of Tissue Specimen From Study Participants
Outcome Time Frame
Study entry (prior to chemotherapy initiation)
Secondary Ids
Secondary Id
CDR0000729843
Secondary Id
U01CA121947
See Also Links
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Estimated
First Submit Date
First Submit QC Date
Study Population
HIV-infected males and females age 18 and older with one of the three malignancy types studied with available diagnostic biopsy material
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Luca Paoluzzi
Investigator Email
lpaoluzzi@montefiore.org
Investigator Phone
6470000000