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Study to Assess Minimal Residual Disease by Next-Generation (NGS) Sequencing in Chronic Lymphocytic Leukemia

Study to Assess Minimal Residual Disease by Next-Generation Sequencing (NGS) in Chronic Lymphocytic Leukemia

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2100046062
Enrollment
Unknown
Registered
2021-05-03
Start date
2021-06-01
Completion date
Unknown
Last updated
2021-12-13

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

Conditions

Chronic lymphocytic leukemia, CLL

Interventions

case series:Nil

Sponsors

Jiangsu Provincial People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1.Aged >=18 years; 2.Diagnosis of CLL that meets the?2016?World Health Organization?(WHO) classification system?for?tumors?of the?hematopoietic?and lymphoid tissues; 3.No previous treatment; 4.Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2; 5.Signed informed consent in keeping with the policies of the hospital.

Exclusion criteria

Exclusion criteria: 1. History of other malignant tumors, except for carcinoma in situ or malignant tumors that can be cured; 2. Active or difficult to control infections such as patients with hepatitis B, hepatitis C or HIV infection; 3. Autoimmune diseases and immunodeficiencies that are difficult to control; 4. Pregnant women and lactating women, female patients of childbearing age must test negative within 7 days before enrollment.

Design outcomes

Primary

MeasureTime frame
The sensitivity of MRD detection by NGS and FCM that allows risk stratification?of the CLL patients;Median overall survival;

Secondary

MeasureTime frame
Percentage of participants with overall?MRD negative status;Percentage of participants with detectable MRD by FCM but without detectable MRD by NGS;Median progression free survival;

Countries

China

Contacts

Public ContactLi Jianyong

Jiangsu Provincial People's Hospital

huayuan.zhu@hotmail.com+86 13813810650

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 6, 2026