Pan-canceR Early DetectIon projeCT

NCT04383353 | Unknown DMC

• 1 other identifier: RSCD2020001
• Study Type: observational
• Target: 14,026
• Locations: 1 country
• Sites: 3

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.

Conditions

Cancer

Keywords

cancer; cell-free DNA (cfDNA) methylation; early detection

Outcome Measures

Primary Outcomes (2)

• The cfDNA methylations profiles of patients with malignancies or benign diseases using pre-treatment biospecimens.

  32 months

• The sensitivity and specificity of multi-cancer early detection and the accuracy of TOO identification via cfDNA methylation based model.

  32 months

Secondary Outcomes (4)

• The sensitivity and specificity of cancer early detection and the accuracy of TOO identification via cfDNA methylation based model in pre-specified subgroups.

  32 months

• 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.

  32 months

• 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.

  32 months

• 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.

  32 months

Study Arms (3)

Cancer arm

Participants with new diagnosis of cancer, from whom a blood sample and contemporaneous tissue samples will be collected.

Benign disease arm

Participants with benign diseases corresponding to the tumor types in the cancer arm, from whom a blood sample and contemporaneous tissue samples will be collected.

Non-tumor arm (Healthy)

Participants with no known presence of malignancies or benign diseases, from whom a blood sample will be collected.

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.
• 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.
• Able to provide a written informed consent.

Sponsors & Collaborators

• Guangzhou Burning Rock Dx Co., Ltd.: lead

Study Sites (3)

Cancer Hospital, Chinese Academy of Medical Sciences & China National Cancer Center

Beijing, Beijing Municipality, 100021, China

Location

Shanghai Ninth People's Hospital, Shanghai JiaoTong University School of Medicine

Shanghai, Shanghai Municipality, 200011, China

Location

Zhongshan Hospital, Fudan University

Shanghai, Shanghai Municipality, 200032, China

Location

Related Publications (1)

• 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.

  PMID: 35027051 DERIVED

MeSH Terms

Conditions

Neoplasms

Study Officials

• Hao Liu, M.D

  Guangzhou Burning Rock Dx Co., Ltd.

  STUDY DIRECTOR

Central Study Contacts

Customer Service Burning Rock

CONTACT

400-689-7600; info@brbiotech.com

Shangli Cai, Ph.D

CONTACT

+86-021 61631938; shangli.cai@brbiotech.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 7, 2020
• First Posted: May 12, 2020
• Study Start: July 21, 2020
• Primary Completion: October 1, 2022
• Study Completion: March 1, 2023
• Last Updated: July 22, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (3)