Skip to content

Prospective clinical study of ctDNA NGS technique in precision typing/efficacy evaluation /MRD monitoring and prognosis of lymphoma patients

Prospective clinical study of ctDNA NGS technique in precision typing/efficacy evaluation /MRD monitoring and prognosis of lymphoma patients

Status
Recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2000034390
Enrollment
Unknown
Registered
2020-07-04
Start date
2020-07-08
Completion date
Unknown
Last updated
2020-07-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

lymphoma

Interventions

case series:Nil

Sponsors

Fujian Medical University Union Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. According to the WORLD Health Organization 2016 classification of hematopoietic and lymphoid tumors, non-Hodgkin's lymphoma was histologically confirmed and untreated. 2. Male or female aged >= 18 years at the time of signing the informed consent. 3. There are measurable lesions. 4. The Eastern Cancer Collaboration (ECOG) Fitness status score is 0, 1 or 2. 5. Life expectancy >= 3 months. 6. Fertile female patients are required to use effective contraception during the study period and at least 120 days after the last administration of the drug, and serum pregnancy test results are negative within 7 days of the first study drug administration. 7. Unsterilized men must agree to use effective contraception during the study period and at least 120 days after the last administration. 8. Written informed consent can be provided and the requirements of the study understood and followed.

Exclusion criteria

Exclusion criteria: 1. Known HIV infection or active hepatitis C infection. 2. Active TB infection is known. 3. Clinically important cardiovascular diseases include: Screening for myocardial infarction in the first 6 months; Screening for unstable angina pectoris in the first 3 months; New York Heart Association Grade III or IV congestive heart failure; A clinically significant history of arrhythmia (e.g., persistent ventricular tachycardia, ventricular fibrillation, tip tortuous ventricular tachycardia, atrial fibrillation). 4. HBsAg positive patients with HBV DNA >= 10000IU/mL were excluded. HBsAg positive patients with HBV DNA < 10000IU/mL and HBsAg negative patients with hbeab-positive patients must be treated with antiviral therapy and undergo monthly HBV DNA screening by PCR before the first administration of the study treatment. 5. There are underlying medical conditions that, in the opinion of the investigator and/or medical examiner, may lead to risks in the acceptance of the drug under study or to difficulties in interpreting the results of safety or efficacy. 6. Is pregnant or breastfeeding, or intends to become pregnant or have a child during the planned trial period. 7. Also participating in another therapeutic clinical trial.

Design outcomes

Primary

MeasureTime frame
ctDNA;

Countries

China

Contacts

Public ContactHaiying Fu

Fujian Medical University Union Hospital

doctorfhy@163.com+86 13774560643

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026