PRediction Of Five Usual Tumors Using Blood Test for Risk Assessment and Early Detection

NCT ID: NCT05874648

Last Updated: 2023-05-25

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 3830 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-07-07
• Study Completion Date: 2024-10-31

Brief Summary

Liquid biopsy technology based on cell-free nucleic acids and protein characteristics has unique advantages and significant application prospects in cancer early detection. The purpose of this study is to collect peripheral blood samples from participants with new diagnosis of cancer and from participants who do not have a diagnosis of cancer in order to develop machine learning models for discovering cancer from non-cancer.

Detailed Description

The PROFUTURE study: A prospective, multicenter, observational, case-control study with collection of peripheral blood and clinical data from clinical networks in order to develop machine learning models for discovering cancer from non-cancer. According to the statistical hypothesis based on expected detection performance, the study will enroll approximately 3,830 participants, including 2,138 participants with cancer (case arm) and approximately 1,692 representative participants without a clinical diagnosis of cancer after medical screening (control arm). Participants pre-matched by age and gender will be divided into training set and validation set in a ratio of approximately 7:3. The validation set will be blinded until the models are developed. Clinical information, demographics, and medical data relevant to cancer status are collected from all participants and their medical records at baseline. The participants of control arm will be asked to report suspected cancer diagnosis status within 6 months after blood collection.

Conditions

Neoplasms; Cancer

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Cancer arm

Multi-cancer early detection test

Intervention Type: DEVICE

Blood collection and multi-cancer early detection test

Non-cancer arm

Multi-cancer early detection test

Intervention Type: DEVICE

Blood collection and multi-cancer early detection test

Interventions

Multi-cancer early detection test

Blood collection and multi-cancer early detection test

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 40-75 years old
• Ability to provide a written informed consent
• Confirmed cancer diagnosis within 30 days after study blood draw, based upon assessment of a pathological specimen
• Have not received any systemic or local antitumor therapy, including but not limited to surgical resection, radiotherapy, hormone therapy, targeted therapy, immunotherapy, interventional therapy, etc.

• 40-75 years old
• Ability to provide a written informed consent
• With clinically and/or pathologically diagnosed benign disease as defined by the protocol or self-reported no history of tumor and no signs of tumor as determined clinically

Exclusion Criteria

• Pregnancy or lactating women
• Known prior or current diagnosis of other types of malignancies comorbidities
• Acute exacerbation of inflammatory condition or severe infection requiring therapy in hospital within 14 days prior to blood draw
• Recipients of organ transplant or prior non-autologous (allogeneic) bone marrow transplant or stem cell transplant
• Recipients of blood transfusion within 30 days prior to study blood draw
• Poor health status or unfit to tolerate blood draw

• Pregnancy or lactating women
• Any tumor history of benign or malignancies
• Acute exacerbation of inflammatory condition or severe infection requiring therapy in hospital within 14 days prior to blood draw
• Recipients of organ transplant or prior non-autologous (allogeneic) bone marrow transplant or stem cell transplant
• Recipients of blood transfusion within 30 days prior to study blood draw
• Poor health status or unfit to tolerate blood draw

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Shanghai Weihe Medical Laboratory Co., Ltd.

INDUSTRY

Sponsor Role: collaborator

Sixth Affiliated Hospital, Sun Yat-sen University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

The Sixth Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, China

Countries

China

Central Contacts

Xiaosheng He, M.D.

Role: CONTACT

hexsheng@mail.sysu.edu.cn

+86-13543490940

Facility Contacts

Xiaosheng He, M.D.

Role: primary

hexsheng@mail.sysu.edu.cn

Other Identifiers

GENIE-PROFUTURE-P

Identifier Type: -

Identifier Source: org_study_id