Clinical implication of plasma-derived circulating tumor DNA (ctDNA) changes in patients with advanced diffuse large B-cell lymphoma treated with immunochemotherapy
- Conditions
- Neoplasms
- Registration Number
- KCT0008632
- Lead Sponsor
- Chonnam National University Hospital Hwasun Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 53
1. Patients with histologically confirmed diffuse large B-cell lymphoma
2. Over 18 years of age
3. Ann Arbor Stage III or IV
4. Bulky mass (= 8 cm) during Ann Arber Stage I or II
5. Patients who have not previously been treated for diffuse large B-cell lymphoma
6. Patients whose activity level is 0-2 based on ECOG
7. One or more two-dimensionally measured lesions (if there is only one lesion, histological confirmation is required)
8. Patients whose proper bone marrow, liver, and renal functions have been confirmed through tests conducted within one month of patient registration
9. Patients whose life expectancy is expected to be more than 6 months
10. For non-medical menopausal patients (pre-menopausal women or women with amenorrhea for less than 1 year), patients who have a negative serum or urine pregnancy test
11. Patients who voluntarily decided to participate in this study and gave written consent
1. HIV-positive patients
2. Women of childbearing potential who are pregnant, lactating, or not using adequate contraception
3. Systemic diseases for which anticancer drug administration is inappropriate
4. Patients receiving other test drugs during clinical trials, or receiving chemotherapy, hormone therapy or immunotherapy in combination
5. Patients with a history of other types of malignant tumors
Study & Design
- Study Type
- Observational Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Compare the nucleotide sequence information and copy number variation obtained from plasma-derived tumor DNA before treatment with the sequence information and copy number variation obtained from tissues. 2. Analyze the correlation between changes in plasma-derived circulating tumor DNA before and after immunotherapy chemotherapy treatment and the resulting progression-free survival rate.
- Secondary Outcome Measures
Name Time Method To compare the correlation between the results of F18 FDG positron emission tomography and plasma-derived circulating tumor DNA changes during immunochemotherapy treatment, and to analyze the possibility of using it as a prognostic tool.