NCT06289959Not yet recruiting
Plasma cfDNA Testing Guiding the Treatment Decisions of DLBCL
A Prospective, Single-Center, Randomized, Controlled Study Guiding the Treatment of Diffuse Large B-Cell Lymphoma Patients Based on Plasma cfDNA Testing
Source: ClinicalTrials.gov · Last updated 4 Mar 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
A prospective, single center, randomized, clinical controlled study to evaluate the efficacy and prognosis differences between precision treatment based on plasma cfDNA testing results and the current conventional diagnostic and treatment practices for DLBCL patients.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- First submitted
- 25 Jan 2024
- Start date
- 25 Feb 2024
- Primary completion date
- 1 Jan 2029
- Lead sponsor
- Second Affiliated Hospital of Soochow University
- Diseases
- Diffuse large B-cell lymphoma
- NCT number
- NCT06289959
What you commit to
- Study type: Interventional
- Planned participants: 30
- From 25 Feb 2024 to the primary completion date, 1 Jan 2029
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients who have undergone autologous stem cell transplantation.
- Other concurrent and uncontrolled diseases that researchers believe may affect the medical condition of patients participating in the study.
Other illness
- Patients with a history of other malignant tumors, except for basal cell carcinoma of the skin or in situ cervical cancer.
- Patients with uncontrolled cardiovascular diseases, coagulation disorders, connective tissue diseases, severe infectious diseases, and other such conditions;
- Patients with mental illness or others known or suspected to be unable to fully comply with the study protocol.
- HbsAg-positive patients who need to undergo HBV-DNA testing and can only be included if they seroconvert. Additionally, if the HbsAg test is negative but the HBcAb test is positive (regardless of HbsAb status), HBV-DNA testing is also required. If the result is positive, inclusion is possible only after seroconversion.
- HIV-infected individuals.
Other
- Primary central nervous system lymphoma.
- Pregnant or lactating women.
Who the study is looking for
- Age ≥ 18 years, gender not specified.
- Newly diagnosed patients with diffuse large B-cell lymphoma (DLBCL) confirmed by histopathological examination. Patients should test positive for plasma cfDNA before treatment (defined as positive for point mutations, CNV, IgH-related fusion, or IG clonal rearrangement) and achieve complete metabolic remission after 6 cycles of R-CHOP chemotherapy (evaluated by Lugano response assessment criteria).
- Patients for whom the researcher predicts a life expectancy of \>6 months.
- Signed informed consent form.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The Second Affiliated Hospital of Soochow University Coordinator of this site? Confirm its status | Suzhou | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.