CancerPREDICTNCT04383353
Pan-canceR Early DetectIon projeCT
An observational study of Cancer, run by Guangzhou Burning Rock Dx Co., Ltd. at 3 sites in China.
Trial summary
PREDICT is a prospective, multi-center study for the early detection of pan-cancer through cell-free DNA (cfDNA) methylation based model, in which approximately 14,000 participants will be enrolled. Read more about this study
- Who is it for?
- Ages 40 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Cancer
- How many people
- 14,026 participants
- Where
- 3 sitesChina
- Study dates
- 21 Jul 2020to Mar 2023
- 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 assigned into three arms, including participants with new diagnosis of malignancy or corresponding benign disease, and participants without the presence of malignant or benign diseases.
Who may be able to join
- Able to provide a written informed consent.
- Able to provide sufficient and qualified blood samples for study tests.
- No prior or undergoing cancer treatment (local or systematic) with either of the following:
- A. Pathologically confirmed cancer diagnosis within 30 (±7) days prior to the study blood draw.
- B. High suspicious for cancer diagnosis by radiological or other routine clinical assessments, with confirmed cancer diagnosis through biopsy or surgical resection within 36 (±7) days after study blood draw.
- Able to provide a written informed consent.
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- Able to provide sufficient and qualified blood samples for study tests.
- Have either of the following:
- A. Pathological confirmed diagnosis of benign diseases within 90 (±7) days prior to the study blood draw, with no prior treatment such as surgical resection.
- B. High suspicious for benign diseases diagnosis by radiological or other routine clinical assessments, with confirmed benign diseases diagnosis within 36 (±7) days after study blood draw.
- Able to provide a written informed consent.
- Able to provide sufficient and qualified blood samples for study tests.
- No cancer related symptoms within 30 days prior to study screening.
- Cancer history with curative treatment completed over 3 years without recurrence prior to study enrollment.
Who cannot join
- Insufficient qualified blood sample for study test.
- During pregnancy or lactation.
- Recipient of organ transplant or prior non-autologous (allogeneic) bone marrow or stem cell transplant.
- Recipient of blood transfusion within 30 days prior to study blood draw.
- With other known malignant tumors or multiple primary tumors.
- Insufficient qualified blood sample for study test.
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- During pregnancy or lactation.
- Recipient of organ transplant or prior non-autologous (allogeneic) bone marrow or stem cell transplant.
- Recipient of blood transfusion within 30 days prior to study blood draw.
- Insufficient qualified blood sample for study test.
- During pregnancy or lactation.
- Recipient of organ transplant or prior non-autologous (allogeneic) bone marrow or stem cell transplant.
- Recipient of blood transfusion within 30 days prior to study blood draw.
- Recipient of anti-infectious therapy within 14 days prior to study blood draw.
- Have received or are undergoing curative cancer treatment within three years prior to study screening.
- With autoimmune or other diseases with severe comorbidities.
Trial locations and contacts
3 sites in 1 country.
China3 sites
Cancer Hospital, Chinese Academy of Medical Sciences & China National Cancer Center
Beijing, Beijing Municipality, 100021
Zhijie Wang, M.D., +86-010-67781331
Jie Wang, M.D., Ph.D
Shanghai Ninth People's Hospital, Shanghai JiaoTong University School of Medicine
Shanghai, Shanghai Municipality, 200011
Xi Yang, M.D., +86-021-23271699
Chenping Zhang, M.D.
Zhongshan Hospital, Fudan University
Shanghai, Shanghai Municipality, 200032
Qiang Gao, M.D., +86-021 64041990, ec@zs-hospital.sh.cn
Jia Fan, M.D., Ph.D
About this study
Official title: Burning Rock Pan-canceR Early DetectIon projeCT (PREDICT): a Prospective, Multicenter Study to Develop and Validate the Performance of a cfDNA Methylation Based Model on Early Cancer Detection
PREDICT is a prospective, multi-center study for the early detection of pan-cancer through cell-free DNA (cfDNA) methylation based model, in which approximately 14,000 participants will be enrolled. The development and validation of the model will be conducted in participants with early stage cancers or benign diseases, along with non-tumor (healthy) individuals through a two-stage approach. The sensitivity and specificity of the model in cancer early detection will be evaluated, and the accuracy of the identification for tissue of origin will be obtained.
- Conditions
- Cancer
- Keywords
- cancer, cell-free DNA (cfDNA) methylation, early detection
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Cancer arm | Participants with new diagnosis of cancer, from whom a blood sample and contemporaneous tissue samples will be collected. | |
| Benign disease arm | Participants with benign diseases corresponding to the tumor types in the cancer arm, from whom a blood sample and contemporaneous tissue samples will be collected. | |
| Non-tumor arm (Healthy) | Participants with no known presence of malignancies or benign diseases, from whom a blood sample will be collected. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The cfDNA methylations profiles of patients with malignancies or benign diseases using pre-treatment biospecimens.
Measured: 32 months
The sensitivity and specificity of multi-cancer early detection and the accuracy of TOO identification via cfDNA methylation based model.
Measured: 32 months
Secondary outcomes (4)
The sensitivity and specificity of cancer early detection and the accuracy of TOO identification via cfDNA methylation based model in pre-specified subgroups.
Measured: 32 months
The sensitivity and specificity of cancer early detection and the accuracy of TOO identification via cfDNA methylation based model in combination with clinicopathological characteristics or other biomarkers.
Measured: 32 months
The examinations related to cancer diagnosis from the participants who were identified as positive cases by cfDNA methylation based model while as healthy individuals by routine medical examinations.
Measured: 32 months
The sensitivity and specificity of cancer early detection and the accuracy of TOO identification via cfDNA methylation based model in the independent training and validation sets.
Measured: 32 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2020
- Study start21 Jul 2020 (estimated)
- Primary completionOct 2022 (estimated)
- Study completionMar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CancerStudies of the same condition, open and under way.
- 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
- 14,026 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guangzhou Burning Rock Dx Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Hao Liu, M.D, Study director, Guangzhou Burning Rock Dx Co., Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04383353
- Sponsor's protocol ID
- RSCD2020001
- Acronym
- PREDICT
- Status last verified
- Jul 2020
- First submitted
- 7 May 2020
- Last updated
- 22 Jul 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Luo B, Ma F, Liu H, Hu J, Rao L, Liu C, Jiang Y, Kuangzeng S, Lin X, Wang C, Lei Y, Si Z, Chen G, Zhou N, Liang C, Jiang F, Liu F, Dai W, Liu W, Gao Y, Li Z, Li X, Zhou G, Li B, Zhang Z, Nian W, Luo L, Liu X. Cell-free DNA methylation markers for differential diagnosis of hepatocellular carcinoma. BMC Med. 2022 Jan 14;20(1):8. doi: 10.1186/s12916-021-02201-3.
PubMed 35027051
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Burning Rock Pan-canceR Early DetectIon projeCT (PREDICT): a Prospective, Multicenter Study to Develop and Validate the Performance of a cfDNA Methylation Based Model on Early Cancer Detection
- ClinicalTrials.gov ID
- NCT04383353
- Acronym / sponsor ID
- PREDICT / RSCD2020001
- Conditions
- Cancer
- Keywords
- cancer, cell-free DNA (cfDNA) methylation, early detection
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 14,026 participants (estimated)
- Lead sponsor
- Guangzhou Burning Rock Dx Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 21 Jul 2020 (estimated)
- Primary completion
- Oct 2022 (estimated)
- Study completion
- Mar 2023 (estimated)
- First posted
- 12 May 2020 (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.
PREDICT is a prospective, multi-center study for the early detection of pan-cancer through cell-free DNA (cfDNA) methylation based model, in which approximately 14,000 participants will be enrolled. The development and validation of the model will be conducted in participants with early stage cancers or benign diseases, along with non-tumor (healthy) individuals through a two-stage approach. The sensitivity and specificity of the model in cancer early detection will be evaluated, and the accuracy of the identification for tissue of origin will be obtained.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cancer arm | – | –Participants with new diagnosis of cancer, from whom a blood sample and contemporaneous tissue samples will be collected. |
| Benign disease arm | – | –Participants with benign diseases corresponding to the tumor types in the cancer arm, from whom a blood sample and contemporaneous tissue samples will be collected. |
| Non-tumor arm (Healthy) | – | –Participants with no known presence of malignancies or benign diseases, from whom a blood sample will be collected. |
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 assigned into three arms, including participants with new diagnosis of malignancy or corresponding benign disease, and participants without the presence of malignant or benign diseases.
Key inclusion criteria (14 listed)
- Able to provide a written informed consent.
- Able to provide sufficient and qualified blood samples for study tests.
- No prior or undergoing cancer treatment (local or systematic) with either of the following:
- A. Pathologically confirmed cancer diagnosis within 30 (±7) days prior to the study blood draw.
- B. High suspicious for cancer diagnosis by radiological or other routine clinical assessments, with confirmed cancer diagnosis through biopsy or surgical resection within 36 (±7) days after study blood draw.
Key exclusion criteria (16 listed)
- Insufficient qualified blood sample for study test.
- During pregnancy or lactation.
- Recipient of organ transplant or prior non-autologous (allogeneic) bone marrow or stem cell transplant.
- Recipient of blood transfusion within 30 days prior to study blood draw.
- With other known malignant tumors or multiple primary tumors.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The cfDNA methylations profiles of patients with malignancies or benign diseases using pre-treatment biospecimens.
Time frame: 32 months
The sensitivity and specificity of multi-cancer early detection and the accuracy of TOO identification via cfDNA methylation based model.
Time frame: 32 months
4 secondary outcomes
The sensitivity and specificity of cancer early detection and the accuracy of TOO identification via cfDNA methylation based model in pre-specified subgroups.
Time frame: 32 months
The sensitivity and specificity of cancer early detection and the accuracy of TOO identification via cfDNA methylation based model in combination with clinicopathological characteristics or other biomarkers.
Time frame: 32 months
The examinations related to cancer diagnosis from the participants who were identified as positive cases by cfDNA methylation based model while as healthy individuals by routine medical examinations.
Time frame: 32 months
The sensitivity and specificity of cancer early detection and the accuracy of TOO identification via cfDNA methylation based model in the independent training and validation sets.
Time frame: 32 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2020.
- Derived from this study: PubMed 35027051Luo B, Ma F, Liu H, Hu J, Rao L, Liu C, Jiang Y, Kuangzeng S, Lin X, Wang C, Lei Y, Si Z, Chen G, Zhou N, Liang C, Jiang F, Liu F, Dai W, Liu W, Gao Y, Li Z, Li X, Zhou G, Li B, Zhang Z, Nian W, Luo L, Liu X. Cell-free DNA methylation markers for differential diagnosis of hepatocellular carcinoma. BMC Med. 2022 Jan 14;20(1):8. doi: 10.1186/s12916-021-02201-3.
- 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.
Hao Liu, M.D study director
Guangzhou Burning Rock Dx Co., Ltd.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer, run by Guangzhou Burning Rock Dx Co., Ltd. at 3 sites 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 14 inclusion and 16 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 22 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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 Customer Service Burning Rock (400-689-7600, info@brbiotech.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The cfDNA methylations profiles of patients with malignancies or benign diseases using pre-treatment biospecimens. (time frame: 32 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?
On the ClinicalTrials.gov record for NCT04383353, which also lists 1 linked publication.
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 22 Jul 2020.