NCT01676805 Tissue Collection for Studies of Lymph Cancer
| NCT ID | NCT01676805 |
| Status | Recruiting |
| Phase | — |
| Sponsor | National Cancer Institute (NCI) |
| Condition | Hodgkin Disease |
| Study Type | OBSERVATIONAL |
| Enrollment | 1,295 participants |
| Start Date | 2012-09-21 |
| Primary Completion | — |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 1,295 participants in total. It began in 2012-09-21.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Background: \- Lab studies help researchers better understand cancer biology. This information may lead to new methods for diagnosing or treating cancer. To develop these studies, researchers want to collect samples from people with cancer or precancer conditions of the lymph system. These conditions include multiple myeloma, different types of lymphoma, and adult leukemia/lymphoma. The samples collected will include blood, urine, bone marrow, and tumor and skin tissue. Objectives: \- To collect tissue samples to study different types of lymph cancer. Eligibility: \- Individuals at least 18 years of age who have a lymphoid cancer or precancer condition. Design: * Participants will be screened with a physical exam and medical history. * Different samples will be collected for study. Blood samples will be collected at the initial testing. More blood samples will be collected at different treatment points. Other liquid samples include urine, bone marrow, and any abnormal fluid. Tumor tissue and skin tissue biopsies will also be collected for study. * Treatment will not be provided as part of this study.
Eligibility Criteria
* Lymphoid Malignancies/Diseases: INCLUSION CRITERIA: * Patients with a known lymphoid malignancy or precursor disease to a lymphoid malignancy, including multiple myeloma, B-cell and T-cell lymphomas: including but not limited to diffuse large B-cell lymphoma (DLBCL), Hodgkin s lymphoma (HL), multiple myeloma (MM), lymphomatoid granulomatosis (LYG) and adult T-cell leukemia/lymphoma (ATL). * Confirmation of pathological diagnosis is required from the Laboratory of Pathology, NCI. Tumor tissue that has been previously collected and is available for study or that can be collected with minimal additional risk to the subject during sampling required for routine patient care or required testing on an NIH research protocol will be used for diagnosis. * Age \>= 18 years of age * ECOG performance 0-2 * Ability of patient or Legally Authorized Representative (LAR) to understand and the willingness to sign a written informed consent document NOTE: Patients enrolling with a LAR must be co-enrolled on another study. INCLUSION FOR APHERESIS: NOTE: This is optional in all patients and will only be requested if the patient is willing, timing allows, and the following criteria are met. * Hemoglobin \>= 10 mg/dL and platelet count \> 75 K/uL * Weight greater than 25 kg * HIV negative * Prothrombin Time - within normal limits * Partial Thromboplastin Time - within normal limits * Medically indicated central line in place or adequate peripheral venous access EXCLUSION CRITERIA: * Pregnant individuals will not be eligible. * Active symptomatic major organ disorder that would increase the risk of biopsy or apheresis, including but not limited to ischemic heart disease, recent myocardial infarction, active congestive heart failure, pulmonary dysfunction. * Active concomitant medical or psychological illnesses that may increase the risk to the subject or inability to obtain informed consent, at the discretion of the principal investigator. NON-LYMPHOID MALIGNANCIES/DISEASES: The following criteria apply only to patients without a known lymphoid malignancy or precursor disease, as described: INCLUSION CRITERIA: -Patients without a known lymphoid malignancy or lymphoid precursor diagnosis who have a planned surgical procedure during which blood or normal lymph node(s)/tissue (i.e., those not with pre-determined likelihood of abnormality/ malignancy) may be obtained for research studies as part of this protocol Patient is appropriate to undergo the surgical procedure planned, and consented for the same, as needed. NOTE: This study will not evaluate eligibility of the patient for surgery. * Age \>= 18 years of age * Must be able and willing to sign informed consent EXCLUSION CRITERIA: * Pregnant individuals will not be eligible * Other active malignancy. NOTE: Patients with a history of curatively treated basal or squamous cell carcinoma or stage 1 melanoma of the skin as well as any in situ carcinoma are eligible. Patients with a malignancy that has been treated with curative intent and who are without evidence of disease for \>=2 years will also be eligible at the discretion of the investigator. * Active concomitant medical or psychological illnesses that may increase the risk to the subject or inability to obtain informed consent, at the discretion of the principal investigator.
Contact & Investigator
Christopher J Melani, M.D.
PRINCIPAL INVESTIGATOR
National Cancer Institute (NCI)
Frequently Asked Questions
Who can join the NCT01676805 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Hodgkin Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT01676805 currently recruiting?
Yes, NCT01676805 is actively recruiting participants. Contact the research team at ncimo_referrals@mail.nih.gov for enrollment information.
Where is the NCT01676805 trial being conducted?
This trial is being conducted at Bethesda, United States, Kingston, Jamaica.
Who is sponsoring the NCT01676805 clinical trial?
NCT01676805 is sponsored by National Cancer Institute (NCI). The principal investigator is Christopher J Melani, M.D. at National Cancer Institute (NCI). The trial plans to enroll 1,295 participants.