Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:28 AM
Ignite Modification Date:
2025-12-25 @ 3:28 AM
NCT ID:
NCT01676805
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01676805
Study Brief:
Protocol Section:
NCT01676805