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

NCT05874648 | Unknown

• 1 other identifier: GENIE-PROFUTURE-P
• Study Type: observational
• Target: 3,830
• Locations: 1 country
• Sites: 1

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.

Conditions

Neoplasms; Cancer

Keywords

Cancer Screening; Blood Test; High-Throughput Nucleotide Sequencing; Circulating cell-free DNA

Outcome Measures

Primary Outcomes (2)

• Sensitivity of predefined five types of cancers and specificity of non-cancers and in different subgroup of cfDNA methylation-based model at 95% confidence interval.

  12 months

• Tissue of origin (TOO) accuracy of five types of cancers of cfDNA methylation-based model at 95% confidence interval.

  12 months

Secondary Outcomes (2)

• Sensitivity, specificity and TOO accuracy of five types of cancers of a multi-omics model at 95% confidence interval.

  12 months

• Sensitivity, specificity and TOO accuracy of cfDNA methylation-based model and multi-omics model in different stages or pathological types of five types of cancers at 95% confidence intervals.

  12 months

Study Arms (2)

Cancer arm

Device: Multi-cancer early detection test

Non-cancer arm

Device: Multi-cancer early detection test

Interventions

Multi-cancer early detection test DEVICE

Blood collection and multi-cancer early detection test

Cancer arm; Non-cancer arm

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 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.

You may qualify if:

• 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.

You may not qualify if:

• 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
• 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
• 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

Sponsors & Collaborators

• Sixth Affiliated Hospital, Sun Yat-sen University: lead
• Shanghai Weihe Medical Laboratory Co., Ltd.: collaborator

Study Sites (1)

The Sixth Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, 510655, China

Location

MeSH Terms

Conditions

Neoplasms

Central Study Contacts

Xiaosheng He, M.D.

CONTACT

+86-13543490940; hexsheng@mail.sysu.edu.cn

Study Design

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

Study Record Dates

• First Submitted: May 16, 2023
• First Posted: May 25, 2023
• Study Start: July 7, 2023
• Primary Completion: April 30, 2024
• Study Completion: October 31, 2024
• Last Updated: May 25, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)