Clinical trial NCT05275036: Assessment of Early-detection Based on Liquid Biopsy in Lymphoid Malignancies
Official title: Assessment of Early-detection Based on Liquid Biopsy in Lymphoid Malignancies: a Multi-center Prospective Observational Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Lymphoma
Keywords: lymphoma, early detection, liquid biopsy
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
Collaborators: name: Guangzhou Burning Rock Dx Co., Ltd.
First posted: 2022-03-11
Enrollment: 493
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Eligible participants will be recruited from the participating medical center and assigned into two arms, including participants with new diagnosis of lymphoid malignancies and benign lymphoid diseases.

Brief summary: ASCEND-LYM is a prospective, multi-center, observational study aimed at detecting early stage lymphoma and constrcuting prognostic model by combined assays of cfDNA methylation and other biomarkers. The study will enroll approximately 493 participants including lymphoid malignancies and benign diseases.


Eligibility criteria: Inclusion Criteria for All Participants:

* Age 40-75 years at the day of consenting to the study.
* Able to provide a written informed consent.

Additional Inclusion Criteria for Cancer Participants:

* No prior cancer treatment (local or systematic) prior to blood draw.
* High suspicious or pathologically confirmed lymphoid malignancies within 42 days prior to blood draw.

Additional Inclusion Criteria for Benign Disease Participants:

* No prior radical treatment of the benign diseases prior to study blood draw
* Pathologically confirmed diagnosis of lymphoid benign diseases within 90 days prior to blood draw.

Exclusion Criteria for All Participants:

* Insufficient qualified blood samples.
* During pregnancy or lactation.
* Recipient of organ transplant or prior non-autologous (allogeneic) bone marrow or stem cell transplant.
* Recipient of blood transfusion within 7 days prior to blood draw.
* Recipient of anti-tumor drugs to treat non-cancer diseases within 30 days prior to blood draw, such as rheumatic drugs (methotrexate, cyclophosphamide, or azathioprine), or endocrine drugs (tamoxifen).

Additional Exclusion Criteria for Cancer Participants:

* With other known malignant tumors or multiple primary tumors.
* Lymphoid malignancies unable to comfirmed by imaging tests or pathological cancer diagnosis within 42 days after the blood draw.

Additional Exclusion Criteria for Benign Disease Participants:

* With other known malignant tumors or comfirmed lymphoid malignancies.
* Lymphoid benign diseases unable to comfirmed by imaging tests or pathological cancer diagnosis within 42 days after the blood draw.

Primary outcomes:
measure: The sensitivity and specificity of early detection model for lymphoma based on cfDNA methylation or combined with other biomarkers.
timeFrame: 12 months
Secondary outcomes:
measure: The sensitivity and specificity of the optimal model in lymphoma patients at different clinical stages.
timeFrame: 12 months
measure: The sensitivity and specificity of the optimal model in different subtypes of lymphoma patients.
timeFrame: 12 months
measure: The rate of high-risk patients found by prognostic model for lymphoma based on cfDNA methylation or combined with other biomarkers.
timeFrame: 24 months
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: SunYat-sen university cancer center
Study officials:
affiliation: Department of Medical Oncology, Sun Yat-sen University Cancer Center
name: Huiqiang Huang, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: