Clinical trial NCT04383353: Pan-canceR Early DetectIon projeCT
Official title: Burning Rock Pan-canceR Early DetectIon projeCT (PREDICT): a Prospective, Multicenter Study to Develop and Validate the Performance of a cfDNA Methylation Based Model on Early Cancer Detection
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cancer
Keywords: cancer
cell-free DNA (cfDNA) methylation
early detection
Lead sponsor: Guangzhou Burning Rock Dx Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2020-05-12
Enrollment: 14026
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Eligible participants will be recruited from medical centers and assigned into three arms, including participants with new diagnosis of malignancy or corresponding benign disease, and participants without the presence of malignant or benign diseases.

Brief summary: PREDICT is a prospective, multi-center study for the early detection of pan-cancer through cell-free DNA (cfDNA) methylation based model, in which approximately 14,000 participants will be enrolled. The development and validation of the model will be conducted in participants with early stage cancers or benign diseases, along with non-tumor (healthy) individuals through a two-stage approach. The sensitivity and specificity of the model in cancer early detection will be evaluated, and the accuracy of the identification for tissue of origin will be obtained.


Eligibility criteria: Inclusion Criteria for Cancer Arm Participants:

* Able to provide a written informed consent.
* Able to provide sufficient and qualified blood samples for study tests.
* No prior or undergoing cancer treatment (local or systematic) with either of the following:
* A. Pathologically confirmed cancer diagnosis within 30 (±7) days prior to the study blood draw.
* B. High suspicious for cancer diagnosis by radiological or other routine clinical assessments, with confirmed cancer diagnosis through biopsy or surgical resection within 36 (±7) days after study blood draw.

Exclusion Criteria for Cancer Arm Participants:

* Insufficient qualified blood sample for study test.
* During pregnancy or lactation.
* Recipient of organ transplant or prior non-autologous (allogeneic) bone marrow or stem cell transplant.
* Recipient of blood transfusion within 30 days prior to study blood draw.
* With other known malignant tumors or multiple primary tumors.

Inclusion Criteria for Benign Disease Arm Participants:

* Able to provide a written informed consent.
* Able to provide sufficient and qualified blood samples for study tests.
* Have either of the following:
* A. Pathological confirmed diagnosis of benign diseases within 90 (±7) days prior to the study blood draw, with no prior treatment such as surgical resection.
* B. High suspicious for benign diseases diagnosis by radiological or other routine clinical assessments, with confirmed benign diseases diagnosis within 36 (±7) days after study blood draw.

Exclusion Criteria for Benign Disease Arm Participants:

* Insufficient qualified blood sample for study test.
* During pregnancy or lactation.
* Recipient of organ transplant or prior non-autologous (allogeneic) bone marrow or stem cell transplant.
* Recipient of blood transfusion within 30 days prior to study blood draw.

Inclusion Criteria for Non-Tumor Arm Participants:

* Able to provide a written informed consent.
* Able to provide sufficient and qualified blood samples for study tests.
* No cancer related symptoms within 30 days prior to study screening.
* Cancer history with curative treatment completed over 3 years without recurrence prior to study enrollment.

Exclusion Criteria for Non-Tumor Arm Participants:

* Insufficient qualified blood sample for study test.
* During pregnancy or lactation.
* Recipient of organ transplant or prior non-autologous (allogeneic) bone marrow or stem cell transplant.
* Recipient of blood transfusion within 30 days prior to study blood draw.
* Recipient of anti-infectious therapy within 14 days prior to study blood draw.
* Have received or are undergoing curative cancer treatment within three years prior to study screening.
* With autoimmune or other diseases with severe comorbidities.

Primary outcomes:
measure: The cfDNA methylations profiles of patients with malignancies or benign diseases using pre-treatment biospecimens.
timeFrame: 32 months
measure: The sensitivity and specificity of multi-cancer early detection and the accuracy of TOO identification via cfDNA methylation based model.
timeFrame: 32 months
Secondary outcomes:
measure: The sensitivity and specificity of cancer early detection and the accuracy of TOO identification via cfDNA methylation based model in pre-specified subgroups.
timeFrame: 32 months
measure: The sensitivity and specificity of cancer early detection and the accuracy of TOO identification via cfDNA methylation based model in combination with clinicopathological characteristics or other biomarkers.
timeFrame: 32 months
measure: The examinations related to cancer diagnosis from the participants who were identified as positive cases by cfDNA methylation based model while as healthy individuals by routine medical examinations.
timeFrame: 32 months
measure: The sensitivity and specificity of cancer early detection and the accuracy of TOO identification via cfDNA methylation based model in the independent training and validation sets.
timeFrame: 32 months
Other outcomes:
Locations:
city: Beijing
country: China
facility: Cancer Hospital, Chinese Academy of Medical Sciences & China National Cancer Center
state: Beijing
city: Shanghai
country: China
facility: Shanghai Ninth People's Hospital, Shanghai JiaoTong University School of Medicine
state: Shanghai
city: Shanghai
country: China
facility: Zhongshan Hospital, Fudan University
state: Shanghai
Study officials:
affiliation: Guangzhou Burning Rock Dx Co., Ltd.
name: Hao Liu, M.D
role: STUDY_DIRECTOR
References:
citation: Luo B, Ma F, Liu H, Hu J, Rao L, Liu C, Jiang Y, Kuangzeng S, Lin X, Wang C, Lei Y, Si Z, Chen G, Zhou N, Liang C, Jiang F, Liu F, Dai W, Liu W, Gao Y, Li Z, Li X, Zhou G, Li B, Zhang Z, Nian W, Luo L, Liu X. Cell-free DNA methylation markers for differential diagnosis of hepatocellular carcinoma. BMC Med. 2022 Jan 14;20(1):8. doi: 10.1186/s12916-021-02201-3.