CClinicalTrials.gg
Status unknownNCT05874648PROFUTUREUpdated May 25, 2023

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

An observational study in Neoplasms and Cancer, sponsored by Sixth Affiliated Hospital, Sun Yat-sen University. Status unknown at 1 site in China. Open to participants aged 40 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-05-25.

Sponsored by Sixth Affiliated Hospital, Sun Yat-sen University · Observational

The sponsor has not verified this record recently (last verified Apr 2023), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
3,830
Ages
40 Years to 75 Years
Sex
All
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Study 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.

Read the 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.

02

Conditions studied

  • Neoplasms
  • Cancer

Keywords

  • Cancer Screening
  • Blood Test
  • High-Throughput Nucleotide Sequencing
  • Circulating cell-free DNA
03

In context

Lead sponsor

Sixth Affiliated Hospital, Sun Yat-sen University is the lead sponsor of 211 studies on the registry; 110 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
40 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
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.

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.

Exclusion criteria

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
05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
3,830 participants (estimated)
Patient registry
No

Groups and cohorts

  • Cancer arm

    Device: Multi-cancer early detection test

  • Non-cancer arm

    Device: Multi-cancer early detection test

Interventions

  • DeviceMulti-cancer early detection test

    Blood collection and multi-cancer early detection test

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What researchers measure

Primary outcomes

  1. 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.

    Time frame: 12 months

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

    Time frame: 12 months

Secondary outcomes

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

    Time frame: 12 months

  2. 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.

    Time frame: 12 months

07

Study locations

1 site
  • The Sixth Affiliated Hospital of Sun Yat-sen University
    Guangzhou, Guangdong 510655, China
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 25, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05874648
Lead sponsor
Sixth Affiliated Hospital, Sun Yat-sen University
Collaborators
Shanghai Weihe Medical Laboratory Co., Ltd.
Responsible party
Sponsor
First posted
May 25, 2023
Start date
Jul 7, 2023 (estimated)
Primary completion
Apr 30, 2024 (estimated)
Completion
Oct 31, 2024 (estimated)
Last update
May 25, 2023

Study contacts

Xiaosheng He, M.D.
Contact
hexsheng@mail.sysu.edu.cn
+86-13543490940

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Apr 2023. You cannot join it, but the record below documents what was studied.

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