a PROspective Case Control Study to Develop and Validate a Blood Test FOr mUlti-caNcers Early Detection（PROFOUND）

NCT06217900 | Recruiting

• 1 other identifier: PROFOUND
• Study Type: observational
• Target: 16,666
• Locations: 1 country
• Sites: 2

Brief Summary

This study is a multi-center, case-control study aiming at developing and blinded testing machine learning-based multiple cancers early detection model by prospectively collecting blood samples from newly diagnosed cancer patients and individuals without confirmed cancer diagnosis.

Conditions

Cancer

Keywords

cell-free DNA; methylation; cancer early detection

Outcome Measures

Primary Outcomes (1)

• The performance of cfDNA methylation-based multiple cancers early detection model in case-control study

  The sensitivity, specificity and tissue origin accuracy of cfDNA methylation-based multiple cancers early detection model in detecting cancer or non-cancer at 95% confidence interval.

  12 months

Secondary Outcomes (3)

• The performance of cfDNA methylation-based multiple cancers early detection model in early stage cancer cases

  12 months

• The performance of multi-omic-based multiple cancers early detection model in case-control study

  12 months

• The performance of different multi-cancer early detection models in different subgroups

  12 months

Other Outcomes (5)

• To develop a questionnaire to evaluate the risk factors in the multi-cancer early screening

  12 months

• To evaluate the performance of multi-omics early detection models in the population with suspected cancer

  12 months

• To simulate the positive predictive value and negative predictive value of different multi-cancer early detection models based on the cancer prevalence and staging data of individuals aged 40-75 years in China using multiple models

  12 months

Study Arms (2)

Case arm

Participants with newly diagnosed cancer of lung, breast, digestive tract, urinary tract and etc.

Control arm

Participants without a cancer diagnosis after routine cancer screening tests.

Eligibility Criteria

• Age: 40 Years - 74 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Confirmed cancers or individuals without confirmed cancer will be invited to participate in this case-control study by a designated consenting professional.

You may qualify if:

• years old
• Clinically and/or pathologically diagnosed cancer
• No prior or undergoing any systemic or local antitumor therapy, including but not limited to surgical resection, radiochemotherapy, endocrinotherapy, targeted therapy, immunotherapy, interventional therapy, etc.
• Able to provide a written informed consent and willing to comply with all part of the protocol procedures

You may not qualify if:

• Pregnancy or lactating women
• Known prior or current diagnosis of other types of malignancies comorbidities
• Severe acute infection (e.g. severe or critical COVID-19, sepsis, etc.) or febrile illness (body temperature of ≥ 38.5 °C) within 14 days prior to screen
• Recipients of organ transplant or prior bone marrow transplant or stem cell transplant
• Recipients of blood transfusion within 30 days prior to screen
• Recipients of therapy in past 14 days prior to screen, including oral or IV antibiotics, glucocorticoid, azacitidine, decitabine, procainamide, hydrazine, arsenic trioxide
• Unsuitable for this trial determined by the researchers
• years old
• Without confirmed cancer diagnosis
• Able to provide a written informed consent and willing to comply with all part of the protocol procedures
• Pregnancy or lactating women
• Known prior or current diagnosis of other types of malignancies comorbidities
• Severe acute infection (e.g. severe or critical COVID-19, sepsis, etc.) or febrile illness (body temperature of ≥ 38.5 °C) within 14 days prior to screen
• Recipients of organ transplant or prior bone marrow transplant or stem cell transplant
• Recipients of blood transfusion within 30 days prior to screen

Sponsors & Collaborators

• Shanghai Weihe Medical Laboratory Co., Ltd.: lead
• Peking University People's Hospital: collaborator

Study Sites (2)

Peking University People's Hospital

Beijing, Beijing Municipality, 100044, China

RECRUITING

Peking University Cancer Hospital and Institute

Beijing, Beijing Municipality, 100083, China

NOT YET RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

blood

MeSH Terms

Conditions

Neoplasms

Study Officials

• Jun Wang

  Peking University People's Hospital

  PRINCIPAL INVESTIGATOR

• Xiaohui Wu

  Shanghai Weihe Medical Laboratory Co., Ltd.

  STUDY DIRECTOR

Central Study Contacts

Yong Qin

CONTACT

+86 186 2629 2273; qinyong@bytedance.com

Study Design

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

Study Record Dates

• First Submitted: December 28, 2023
• First Posted: January 23, 2024
• Study Start: December 28, 2023
• Primary Completion (Estimated): October 31, 2026
• Study Completion (Estimated): March 31, 2027
• Last Updated: January 23, 2024

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)