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 @ 5:07 AM
Ignite Modification Date:
2025-12-25 @ 5:07 AM
NCT ID:
NCT02987127
Eligibility Criteria:
Inclusion Criteria:
1. The patients must have histologically confirmed low-grade mucosa-associated
2. lymphoid tissue lymphoma of extragastric sites.
3. Patients must have evaluable disease by physical examination, endoscopy (also include colonfibroscopy, and bronchoscopy) or computed tomography.
4. Patients must receive examination of documented HP infection or not before treatment, which will be evaluated by the following tests: histology, rapid urease test (CLO-test), C-13 urease breath test and serology.
5. Patients must have either stage IE or IIE-1 disease, according to an adaptation of the Ann Arbor staging system modified by Musshoff for primary extranodal lymphoma.
6. Patients must have signed the informed consent and agree to provide achieved pathologic material for immunohistochemical staining of BCL10, NF-KB, BAFF, CagA, CagA-signaling molecules, for fluorescence in situ hybridization study for t(11;18)(q21;q21)/API2-MALT1 and t(14;18)(q32;q21)/IGH-MALT1 determination, and for PCR of Chlamydia psittaci and Borrelia burgdorferi.
7. Patients must have signed the informed consent and agree to provide achieve blood samples for CYP2C19 genetic polymorphisms evaluation and potential serum molecular studies, such as serum BAFF level
Exclusion Criteria:
1. In the diagnosis of the disease over the past five years with a history of other cancers but non-melanoma skin cancer, breast and cervical carcinoma in situ carcinoma in situ (leafy or tubular) can still meet the conditions of admission to this case study
2. Patients receiving chemotherapy or radiotherapy of nodules outside the low-grade malignant lymphoma, but has not yet been cured, the excluded
3. The second more, and not in the lymph nodes adjacent to the tumor (IIE-2 period or more), the excluded
4. The state can not afford this clinical cardiopulmonary ㄧ inspection after the test series, the excluded
5. suffering from primary gastric outside MALToma before and had received chemotherapy or radiation therapy in patients of.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
21 Years
Study:
NCT02987127
Study Brief:
Protocol Section:
NCT02987127