Lung CancerNCT01567722
Collecting and Studying Tissue Samples From Patients With HIV-Associated Malignancies
An observational study of Lung Cancer and Lymphoma, run by AIDS Malignancy Consortium at 14 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer, Lymphoma
- What is being tested?
- DNA analysis, RNA analysis and gene expression analysis
- How many people
- 114 participants
- Where
- 14 sitesUnited States
- Study dates
- 2 Jan 2013to 14 Jan 2022
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- 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
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
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
United States14 sites
UNC Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, 27599
John H. Stroger Hospital of Cook County
Chicago, Illinois, 60612
Moores UCSD Cancer Center
La Jolla, California, 92093-0658
UCLA Clinical AIDS Research and Education (CARE) Center
Los Angeles, California, 90095-1793
University of Miami
Miami, Florida, 33136
Louisiana State University Public Hospital
New Orleans, Louisiana, 70112
Memorial Sloan Kettering Cancer Center
New York, New York, 10021
University of Pennsylvania - Abramson Cancer Center at Pennsylvania Hospital
Philadelphia, Pennsylvania, 19106
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111
Harborview Madison Clinic
Seattle, Washington, 98104
Virginia Mason Medical Center
Seattle, Washington, 98111
Washington University School of Medicine
St Louis, Missouri, 63110
Albert Einstein Cancer Center at Albert Einstein College of Medicine
The Bronx, New York, 10461
George Washington University
Washington D.C., District of Columbia, 20052
About this study
Official title: Tissue Acquisition for Analysis of Prognostic Factors, Immunology, and Genetic Progression of HIV-1 Associated Malignancies
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.
Read the 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.
- Conditions
- Lung Cancer, Lymphoma
- Being tested
- DNA analysis, RNA analysis, gene expression analysis, polymorphism analysis, biologic sample preservation procedure
- Keywords
- HIV infection, adult diffuse large cell lymphoma, non-small cell lung cancer, AIDS-related diffuse large cell lymphoma
- Medical subject headings
- Lung Neoplasms, Lymphoma, HIV Infections, Lymphoma, Large B-Cell, Diffuse, Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DNA analysisGenetic
This sample will be used for germline DNA analysis.
RNA analysisGenetic
RNA will be sheared, reverse transcribed, and sequenced to assess transcribed sequences.
gene expression analysisGenetic
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.
polymorphism analysisGenetic
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.
biologic sample preservation procedureOther
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.
flow cytometryOther
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.
medical chart reviewOther
Participants will be followed prospectively to record the types of treatment given, and treatment outcome and toxicity.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 | |
| HIV-positive lung cancer cases | Tissue collection for genomic sequencing from persons with a diagnosis of HIV and lung cancer. Receives: 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 | |
| HIV-positive cervical cancer cases | Tissue specimen collection from HIV positive patients with a diagnosis of cervical cancer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Collection of Tissue Specimen From Study Participants
Summary of the specimens available by study arm
Measured: Study entry (prior to chemotherapy initiation)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2012 (estimated)
- Study start2 Jan 2013
- Primary completion14 Jan 2022
- Study completion14 Jan 2022
Why it stopped: Sponsor directive
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 114 participants (actual)
Sponsor and investigators
- Lead sponsor
- AIDS Malignancy Consortium
- Sponsor type
- Research network
- Collaborators
- National Cancer Institute (NCI), The Emmes Company, LLC, AIDS and Cancer Specimen Resource, University of Arkansas
- Responsible party
- Sponsor
- Investigators
- Lee Ratner, MD, PhD, Principal investigator, Washington University Siteman Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01567722
- Sponsor's protocol ID
- AMC-083
- Other IDs
- CDR0000729843, U01CA121947
- Status last verified
- Mar 2023
- First submitted
- 29 Mar 2012
- Last updated
- 16 Mar 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Results will be submitted to dBGaP
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tissue Acquisition for Analysis of Prognostic Factors, Immunology, and Genetic Progression of HIV-1 Associated Malignancies
- ClinicalTrials.gov ID
- NCT01567722
- Acronym / sponsor ID
- AMC-083
- Conditions
- Lung Cancer, Lymphoma
- Keywords
- HIV infection, adult diffuse large cell lymphoma, non-small cell lung cancer, AIDS-related diffuse large cell lymphoma
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Sponsor directive
- Enrolment
- 114 participants (actual)
- Lead sponsor
- AIDS Malignancy ConsortiumResearch network
- Collaborators
- National Cancer Institute (NCI), The Emmes Company, LLC, AIDS and Cancer Specimen Resource, University of Arkansas
- Study start
- 2 Jan 2013 (actual)
- Primary completion
- 14 Jan 2022 (actual)
- Study completion
- 14 Jan 2022 (actual)
- First posted
- 30 Mar 2012 (estimated)
- Results
- Posted 16 Mar 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| HIV-positive diffuse large B-cell lymphoma cases | – | Genetic: DNA analysis, Genetic: RNA analysis, Genetic: gene expression analysis, Genetic: polymorphism analysis, Other: biologic sample preservation procedure, Other: flow cytometry, Other: medical chart reviewTissue collection for genomic sequencing from persons with a diagnosis of HIV and diffuse large B-cell lymphoma. |
| HIV-positive lung cancer cases | – | Genetic: DNA analysis, Genetic: RNA analysis, Genetic: gene expression analysis, Genetic: polymorphism analysis, Other: biologic sample preservation procedure, Other: flow cytometry, Other: medical chart reviewTissue 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DNA analysisThis sample will be used for germline DNA analysis. | Genetic | HIV-positive diffuse large B-cell lymphoma cases, HIV-positive lung cancer cases |
| RNA analysisRNA will be sheared, reverse transcribed, and sequenced to assess transcribed sequences. | Genetic | HIV-positive diffuse large B-cell lymphoma cases, HIV-positive lung cancer cases |
| gene expression analysisGenomic 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. | Genetic | HIV-positive diffuse large B-cell lymphoma cases, HIV-positive lung cancer cases |
| polymorphism analysisGenomic 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. | Genetic | HIV-positive diffuse large B-cell lymphoma cases, HIV-positive lung cancer cases |
| biologic sample preservation procedureGenomic 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. | Other | HIV-positive diffuse large B-cell lymphoma cases, HIV-positive lung cancer cases |
| flow cytometryInformation 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. | Other | HIV-positive diffuse large B-cell lymphoma cases, HIV-positive lung cancer cases |
| medical chart reviewParticipants will be followed prospectively to record the types of treatment given, and treatment outcome and toxicity. | Other | HIV-positive diffuse large B-cell lymphoma cases, HIV-positive lung cancer cases |
Primary outcome
Collection of Tissue Specimen From Study Participants
Time frame: Study entry (prior to chemotherapy initiation)
Summary of the specimens available by study arm
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Clinicaltrials.gov summary of trialLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Results will be submitted to dBGaP
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lee Ratner, MD, PhD principal investigator
Washington University Siteman Cancer Center
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Cancer and Lymphoma, run by AIDS Malignancy Consortium at 14 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 16 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 Mar 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Collection of Tissue Specimen From Study Participants (time frame: Study entry (prior to chemotherapy initiation)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2023.