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 @ 4:57 AM
Ignite Modification Date:
2025-12-25 @ 4:57 AM
NCT ID:
NCT01672918
Eligibility Criteria:
* INCLUSION CRITERIA:
To qualify for enrollment, patients must meet all of the following:
1. Fulfill current criteria for the diagnosis of ALPS, which includes documented chronic nonmalignant lymphadenopathy and/or splenomegaly, and either greater than or equal to 1.5% T-cell receptor alpha/beta+ DNTs in the peripheral blood or confirmed RAS mutation with or without elevated alpha/beta DNTs.
2. Be enrolled in ALPS natural history protocol #93-I-0063.
3. Have 1 or more of the following:
1. Sudden enlargement of at least 1 lymph node or group of lymph nodes over baseline.
2. Systemic symptoms suspicious for lymphoma (i.e., loss of weight, loss of appetite, fatigue, night sweats, fever, and pruritus).
3. A histologically proven diagnosis of lymphoma or other malignancy.
4. Be 5 years of age or older.
EXCLUSION CRITERIA:
Patients will be excluded if any of the following is present:
1. Concurrent proven infection or inflammatory disease (e.g., sarcoidosis), which itself often shows increased FDG uptake by PET and which could interfere with the interpretation of study results.
2. Hyperglycemia (regardless of etiology) determined by fasting glucose of \>200 mg/dL
3. Weight in excess of 400 lb, which will exceed the weight limit for the scanner table.
4. Pregnancy or breast-feeding. For women of childbearing potential, a negative urine or serum pregnancy test is required within 24 hours prior to an FDG-PET/CT scan.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
5 Years
Maximum Age:
99 Years
Study:
NCT01672918
Study Brief:
Protocol Section:
NCT01672918