Collecting and Studying Tissue Samples From Patients With HIV-Associated Malignancies (NCT01567722) | Clinical Trial Compass
TerminatedNot Applicable
Collecting and Studying Tissue Samples From Patients With HIV-Associated Malignancies
Stopped: Sponsor directive
United States114 participantsStarted 2013-01-02
Plain-language 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.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 CON…
What they're measuring
1
Collection of Tissue Specimen From Study Participants
Timeframe: Study entry (prior to chemotherapy initiation)