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

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

NCT ID: NCT05874648

Condition: Neoplasms
Cancer

Conditions: Keywords:
Cancer Screening
Blood Test
High-Throughput Nucleotide Sequencing
Circulating cell-free DNA

Study type: Observational

Overall status: Not yet recruiting

Study design:

Time perspective: Prospective

Intervention:

Intervention type: Device
Intervention name: Multi-cancer early detection test
Description: Blood collection and multi-cancer early detection test
Arm group label: Cancer arm
Arm group label: Non-cancer arm

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.

Criteria for eligibility:

Study pop:
Eligible participants will be recruited from medical centers and communities. Participants will be assigned into two arms, including participants with new diagnosis of cancer and participants without a clinical diagnosis of cancer after medical screening. Demographic and cancer risk-related characteristics (eg, age, gender, smoking status, alcohol consumption) will be collected from all enrolled subjects.

Sampling method: Non-Probability Sample
Criteria:
Inclusion Criteria for Cancer Arm Participants: - 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. Exclusion Criteria for Cancer Arm Participants: - 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 Inclusion Criteria for Non-Cancer Arm Participants: - 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 for Non-Cancer Arm Participants: - 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

Gender: All

Minimum age: 40 Years

Maximum age: 75 Years

Healthy volunteers: Accepts Healthy Volunteers

Locations:

Facility:
Name: The Sixth Affiliated Hospital of Sun Yat-sen University

Address:
City: Guangzhou
Zip: 510655
Country: China

Contact:
Last name: Xiaosheng He, M.D.
Email: hexsheng@mail.sysu.edu.cn

Start date: July 7, 2023

Completion date: October 31, 2024

Lead sponsor:
Agency: Sixth Affiliated Hospital, Sun Yat-sen University
Agency class: Other

Collaborator:
Agency: Shanghai Weihe Medical Laboratory Co., Ltd.
Agency class: Industry

Source: Sixth Affiliated Hospital, Sun Yat-sen University

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05874648