NeoplasmsPROFUTURENCT05874648
PRediction Of Five Usual Tumors Using Blood Test for Risk Assessment and Early Detection
An observational study of Neoplasms and Cancer, run by Sixth Affiliated Hospital, Sun Yat-sen University at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 40 to 75 yearsHealthy volunteers can take part
- What is being tested?
- Multi-cancer early detection test
- Type of treatment
- Medical device
- How many people
- 3,830 participants
- Where
- 1 siteChina
- Study dates
- 7 Jul 2023to 31 Oct 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
China1 site
The Sixth Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, 510655
Xiaosheng He, M.D., hexsheng@mail.sysu.edu.cn
About this study
Official title: Peripheral Blood cfDNA Methylation, Fragmentation, and Proteomics for Multiple Cancers Early Detection: a Multicenter, Prospective, Observational, Case-control Study
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.
- Being tested
- Multi-cancer early detection test
- Keywords
- Cancer Screening, Blood Test, High-Throughput Nucleotide Sequencing, Circulating cell-free DNA
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multi-cancer early detection testDevice
Blood collection and multi-cancer early detection test
| Study group | Role | What they receive |
|---|---|---|
| Cancer arm | Not described Receives: Device: Multi-cancer early detection test | |
| Non-cancer arm | Not described Receives: Device: Multi-cancer early detection test |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
Tissue of origin (TOO) accuracy of five types of cancers of cfDNA methylation-based model at 95% confidence interval.
Measured: 12 months
Secondary outcomes (2)
Sensitivity, specificity and TOO accuracy of five types of cancers of a multi-omics model at 95% confidence interval.
Measured: 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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2023
- Study start7 Jul 2023 (estimated)
- Primary completion30 Apr 2024 (estimated)
- Study completion31 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NeoplasmsStudies of the same condition, open and under way.
- More trials run by Sixth Affiliated Hospital, Sun Yat-sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 3,830 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Shanghai Weihe Medical Laboratory Co., Ltd.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05874648
- Sponsor's protocol ID
- GENIE-PROFUTURE-P
- Acronym
- PROFUTURE
- Status last verified
- Apr 2023
- First submitted
- 16 May 2023
- Last updated
- 25 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Peripheral Blood cfDNA Methylation, Fragmentation, and Proteomics for Multiple Cancers Early Detection: a Multicenter, Prospective, Observational, Case-control Study
- ClinicalTrials.gov ID
- NCT05874648
- Acronym / sponsor ID
- PROFUTURE / GENIE-PROFUTURE-P
- Keywords
- Cancer Screening, Blood Test, High-Throughput Nucleotide Sequencing, Circulating cell-free DNA
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 3,830 participants (estimated)
- Lead sponsor
- Sixth Affiliated Hospital, Sun Yat-sen UniversityUniversity, hospital or other
- Collaborators
- Shanghai Weihe Medical Laboratory Co., Ltd.
- Study start
- 7 Jul 2023 (estimated)
- Primary completion
- 30 Apr 2024 (estimated)
- Study completion
- 31 Oct 2024 (estimated)
- First posted
- 25 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cancer arm | – | Device: Multi-cancer early detection test |
| Non-cancer arm | – | Device: Multi-cancer early detection test |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multi-cancer early detection testBlood collection and multi-cancer early detection test | Device | Cancer arm, Non-cancer arm |
Primary outcome
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
Tissue of origin (TOO) accuracy of five types of cancers of cfDNA methylation-based model at 95% confidence interval.
Time frame: 12 months
2 secondary outcomes
Sensitivity, specificity and TOO accuracy of five types of cancers of a multi-omics model at 95% confidence interval.
Time frame: 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.
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neoplasms and Cancer, run by Sixth Affiliated Hospital, Sun Yat-sen University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xiaosheng He, M.D. (+86-13543490940, hexsheng@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 May 2023.