CancerNCT04817306
Pan-canceR Early DetectIon projeCT (PREDICT)
An observational study of Cancer, run by Shanghai Zhongshan Hospital at 3 sites in China.
Trial summary
PREDICT is a prospective, multicenter 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
- What is being tested?
- Multi-cancer early detection test
- Type of treatment
- Medical device
- How many people
- 14,026 participants
- Where
- 3 sitesChina
- Study dates
- 29 Mar 2021to 31 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 cancer or corresponding benign diseases, and participants without the presence of malignancies or benign diseases.
Who may be able to join
- Ability to provide a written informed consent
- 40-75 years old
- Confirmed diagnosis of a cancer or highly suspicious cases of cancer within 42 days prior to study blood draw. Tumor types in this study include lung cancer, colorectal cancer, liver cancer, ovarian cancer, gastric cancer, esophageal cancer, pancreatic cancer, biliary tract cancer, squamous cell carcinoma of the head and neck (except nasopharyngeal carcinoma)
- No prior or ongoing anti-cancer therapy (local or systematic) prior to study blood draw
- Histopathologically confirmed or highly suspicious for benign diseases corresponding to the tumor types in the Cancer Arm within 90 days prior to study blood draw, or highly suspicious for benign diseases corresponding to the tumor types in Cancer Arm by radiological assessments or other clinical examinations
- No prior treatment of benign disease prior to study blood draw
Who cannot join
- Inability to comply with study procedures
- Pregnancy or lactating women
- Recipients of organ transplant or prior non-autologous (allogeneic) bone marrow transplant or stem cell transplant
- Recipients of blood transfusion within 7 days prior to study blood draw
- Recipients of any anti-cancer therapy within 30 days prior to study blood draw, due to diseases other than cancer
- Known prior diagnosis of malignancies
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- Other current malignant diseases or multiple primary tumors
- No confirmed diagnosis of cancer by histopathological or radiological assessments within 42 days of study blood draw, or diagnosis of a benign disease by histopathological assessments, or inability to characterize whether the lesion is malignant or benign
- Non-small-cell lung cancer patients with ground-class nodularity by radiological examination
- Current or history of malignancies or precancerous lesions
- No confirmed diagnosis or inability to characterize a benign disease by radiological, endoscopic or histopathological assessments within 42 days of study blood draw
- Inclusion Criteria for Non-tumor (Healthy) Arm Participants:
- No cancer-related symptoms or discomfort within 30 days prior to study blood draw
- No clinically significant finding by LDCT or abdominal ultrasound
- No clinically significant finding by breast ultrasound or Molybdenum Target Mammography Detection, or cervical liquid-based cell (TCT) detection for female participants
- No active hepatitis B or hepatitis C infection
- Exclusion Criteria for Non-tumor (Healthy) Arm Participants:
- Prior or ongoing treatment of cancer within 3 years prior to study blood draw
- Unexplained weight loss
- Prior or current major diseases, including COPD, interstitial pneumonia, viral hepatitis, liver cirrhosis, inflammatory bowel disease
- Prior and current adenoma of the intestine and polyp of the intestine
- Changes in bowel habits, bowel abnormalities, hematochezia within 30 days prior to study blood draw
- Uncontrolled hypertension and other cardiovascular diseases
- Currently severe bleeding disorders
- Major surgery within 24 weeks prior to study blood draw
- Infection requiring anti-microbial therapy within 24 weeks prior to study blood draw
- Current autoimmunity disease
- Clinically significant or uncontrolled comorbidities which, in the investigator's opinion, should be excluded
Trial locations and contacts
3 sites in 1 country.
China3 sites, 3 recruiting
- Not yet recruiting
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
- Not yet recruiting
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.
- Recruiting
Zhongshan Hospital, Fudan University
Shanghai, Shanghai Municipality, 200032
Qiang Gao, M.D., +86-021 64041990, gao.qiang@zs-hospital.sh.cn
Jia Fan, M.D., Ph.D
About this study
Official title: A Prospective, Multicenter Study on Development and Validation of the Performance of a cfDNA Methylation-based Model for Early Cancer Detection (Pan-canceR Early DetectIon projeCT, PREDICT Study)
PREDICT is a prospective, multicenter 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 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
- Being tested
- Multi-cancer early detection test
- 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.
Multi-cancer early detection testDevice
Blood collection and multi-cancer early detection testing
| Study group | Role | What they receive |
|---|---|---|
| Cancer Arm | Participants with new diagnosis of cancer, from whom blood samples will be collected Receives: Device: Multi-cancer early detection test | |
| Benign Diseases Arm | Participants with benign diseases corresponding to the tumor types in the Cancer Arm, from whom blood samples will be collected Receives: Device: Multi-cancer early detection test | |
| Non-tumor (Healthy) Arm | Participants without known presence of malignancies or benign diseases, from whom blood samples will be collected 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 early detection of cancer and Tissue of origin (TOO) accuracy of a cfDNA methylation-based model when specificity is 90%, 95% or 98% in healthy participants
Measured: 24 months
Sensitivity and specificity of early detection of cancer and TOO accuracy of a cfDNA methylation-based model
Measured: 24 months
Secondary outcomes (3)
Sensitivity, specificity and TOO accuracy of a cfDNA methylation-based model in various types of cancer
Measured: 24 months
Sensitivity, specificity and TOO accuracy of a cfDNA methylation-based model in different stages of cancer
Measured: 24 months
Sensitivity, specificity and TOO accuracy of a cfDNA methylation-based model, in combination with clinical characteristics and other biomarkers
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2021
- Study start29 Mar 2021
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Mar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Shanghai Zhongshan Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Guangzhou Burning Rock Dx Co., Ltd.
- Responsible party
- Sponsor
- Investigators
- Jia Fan, M.D., Ph.D, Principal investigator, Shanghai Zhongshan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04817306
- Sponsor's protocol ID
- RSCD2020001
- Status last verified
- Mar 2021
- First submitted
- 23 Mar 2021
- Last updated
- 30 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
- 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 30 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicenter Study on Development and Validation of the Performance of a cfDNA Methylation-based Model for Early Cancer Detection (Pan-canceR Early DetectIon projeCT, PREDICT Study)
- ClinicalTrials.gov ID
- NCT04817306
- Acronym / sponsor ID
- 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
- Shanghai Zhongshan HospitalUniversity, hospital or other
- Collaborators
- Guangzhou Burning Rock Dx Co., Ltd.
- Study start
- 29 Mar 2021 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Mar 2023 (estimated)
- First posted
- 26 Mar 2021 (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, multicenter 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 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 | – | Device: Multi-cancer early detection testParticipants with new diagnosis of cancer, from whom blood samples will be collected |
| Benign Diseases Arm | – | Device: Multi-cancer early detection testParticipants with benign diseases corresponding to the tumor types in the Cancer Arm, from whom blood samples will be collected |
| Non-tumor (Healthy) Arm | – | Device: Multi-cancer early detection testParticipants without known presence of malignancies or benign diseases, from whom blood samples 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 cancer or corresponding benign diseases, and participants without the presence of malignancies or benign diseases.
Key inclusion criteria (6 listed)
- Ability to provide a written informed consent
- 40-75 years old
- Confirmed diagnosis of a cancer or highly suspicious cases of cancer within 42 days prior to study blood draw. Tumor types in this study include lung cancer, colorectal cancer, liver cancer, ovarian cancer, gastric cancer, esophageal cancer, pancreatic cancer, biliary tract cancer, squamous cell carcinoma of the head and neck (except nasopharyngeal carcinoma)
- No prior or ongoing anti-cancer therapy (local or systematic) prior to study blood draw
- Histopathologically confirmed or highly suspicious for benign diseases corresponding to the tumor types in the Cancer Arm within 90 days prior to study blood draw, or highly suspicious for benign diseases corresponding to the tumor types in Cancer Arm by radiological assessments or other clinical examinations
Key exclusion criteria (28 listed)
- Inability to comply with study procedures
- Pregnancy or lactating women
- Recipients of organ transplant or prior non-autologous (allogeneic) bone marrow transplant or stem cell transplant
- Recipients of blood transfusion within 7 days prior to study blood draw
- Recipients of any anti-cancer therapy within 30 days prior to study blood draw, due to diseases other than cancer
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 testing | Device | Benign Diseases Arm, Cancer Arm, Non-tumor (Healthy) Arm |
Primary outcome
Sensitivity of early detection of cancer and Tissue of origin (TOO) accuracy of a cfDNA methylation-based model when specificity is 90%, 95% or 98% in healthy participants
Time frame: 24 months
Sensitivity and specificity of early detection of cancer and TOO accuracy of a cfDNA methylation-based model
Time frame: 24 months
3 secondary outcomes
Sensitivity, specificity and TOO accuracy of a cfDNA methylation-based model in various types of cancer
Time frame: 24 months
Sensitivity, specificity and TOO accuracy of a cfDNA methylation-based model in different stages of cancer
Time frame: 24 months
Sensitivity, specificity and TOO accuracy of a cfDNA methylation-based model, in combination with clinical characteristics and other biomarkers
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2021.
- 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.
Jia Fan, M.D., Ph.D principal investigator
Shanghai Zhongshan Hospital
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 Shanghai Zhongshan Hospital 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 6 inclusion and 28 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 30 Mar 2021. 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 Qiang Gao, M.D. (+86 021 64041990, gao.qiang@zs-hospital.sh.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity of early detection of cancer and Tissue of origin (TOO) accuracy of a cfDNA methylation-based model when specificity is 90%, 95% or 98% in healthy participants (time frame: 24 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 30 Mar 2021.