Early Detection of CancerNCT04405557
The PREDICT Study: Prospective Early Detection In a Population at High-risk for Common Malignant Tumor
An observational study of Early Detection of Cancer, run by Geneplus-Beijing Co. Ltd. at 8 sites in China.
Trial summary
This is a observational, multicenter study, monitoring the circulating tumor DNA (ctDNA) in people who is at risk of cancers，assessing the sensitivity and specificity of ctDNA detection in early screening of pan-carcinoma. Read more about this study
- Who is it for?
- Ages 45 years and older
- Conditions the study is for
- Early Detection of Cancer
- How many people
- 757 participants
- Where
- 8 sitesChina
- Study dates
- 12 Nov 2019to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 45 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: People with positive tumor protein marker or cancer screening.
Who may be able to join
- Patients aged at or over 45 years old.
- Patients who with one or more of the following situations:
- In AFP (>20UG/L), CA125 (>70U/ml), CEA (>7ng/ml) and CA199 (>60U/ml), more than one item was abnormal for two consecutive times within one month.
- Patients with viral hepatitis (Hepatitis B / C surface antigen positive with liver function damage.
- Patients with liver nodules detected by ultrasound and hemangioma excluded.
- Patients with compensated cirrhosis.
Show all 18Show fewer
- CA125>35U/ml and HE4 was abnormal (the reference value of HE4 in premenopausal and postmenopausal women was 68.96 pmol/L and 114.90 pmol/L respectively).
- Patients with ovarian masses found by ultrasonography (premenopausal > 5cm, postmenopausal > 3.5cm).
- Patients with pancreatic space-occupying found by ultrasonography.
- Patients with BI-RADS grade 4 or above by ultrasound or mammography.
- CA125>35U/ml and BI-RADS above grade 3 by ultrasound or mammography.
- CA153>25U/ml and BI-RADS above grade 3 by ultrasound or mammography.
- Family genetic history of breast cancer and ovarian cancer, and BI-RADS above grade 3 by ultrasound or mammography.
- Patients with a positive fecal occult blood test and haemorrhoids excluded
- Patients with a positive fecal occult blood test and positive CEA
- More than 2 items were abnormal in PGI, PGR and G-17 (criteria: PGI≤70 UG/L, PGR≤7.0, G-17≤1 pmol/L or G-17≥15 pmol/L).
- Ability to collect specimens from each time point and provide corresponding clinical information.
- Understand the research plan and voluntarily participate in the study, sign the informed consent form.
Who cannot join
- Patients with previous or present cancer.
- Patients with serious diseases, especially those with a survival period of less than 3 years.
- Patients with factors that affect the diagnosis of the disease (such as MRI related cardiac pacemakers, ferromagnetic implants, etc.).
- Patients with a known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation.
- Women who are pregnant or preparing for pregnancy.
- Patients who voluntarily withdraw for any reason.
- Patients who cannot complete the research plan
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
China8 sites
Chinese PLA General Hospital
Beijing, Beijing Municipality
China-Japan Union Hospital of Jilin University
Changchun, Jilin, 130033
Xiangya Hospital Central South University
Changsha, Hunan, 410008
Sichuan Provincial People's Hospital
Chengdu, Sichuan, 610072
The First Affiliated Hospital of Jinzhou Medical University
Jinzhou, Liaoning, 121001
Jiangsu Province Hospital
Nanjing, Jiangsu, 210029
Shenzhen People's Hospital
Shenzhen, Guangdong, 518020
Henan Provincial People's Hospital
Zhengzhou, Henan, 450003
About this study
Official title: Study on the Application of ctDNA in a Population at High-risk for Common Malignant Tumor
This is a observational, multicenter study, monitoring the circulating tumor DNA (ctDNA) in people who is at risk of cancers，assessing the sensitivity and specificity of ctDNA detection in early screening of pan-carcinoma.
Read the detailed description
2000 patients with positive tumor protein markers or cancer screening were recruited. All patients were tested for ctDNA at enrollment and followed up at 6 months and 1 year. The study was completed at the time of cancer diagnosis or the longest follow-up time (1 year).
- Conditions
- Early Detection of Cancer
- Keywords
- Pan-cancer, cancer screening, ctDNA
What is being measured
The primary outcome is the main question the study is designed to answer.
Analysis of ctDNA for early detection in cancer high-risk population.
To evaluate the sensitivity, specificity and positive predictive value of ctDNA for screening in high-risk population. Including the following six types of cancer: hepatocellular carcinoma, pancreatic cancer, ovarian cancer, breast cancer, colorectal cancer and gastric cancer.
Measured: 1 year
Secondary outcomes (1)
Window period from ctDNA positive to cancer diagnosis.
To evaluate the time from ctDNA positive to cancer diagnosis for patients diagnosed with cancer during the trial period.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2020
- Study start12 Nov 2019
- Primary completion16 Jan 2022
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Early Detection of 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 only
- Time perspective
- Prospective
- Enrolment
- 757 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Geneplus-Beijing Co. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Chinese PLA General Hospital
- Responsible party
- Sponsor
- Investigators
- Qiang Zeng, MD, Principal investigator, Chinese PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04405557
- Sponsor's protocol ID
- PREDICT
- Status last verified
- Aug 2025
- First submitted
- 9 May 2020
- Last updated
- 4 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the Application of ctDNA in a Population at High-risk for Common Malignant Tumor
- ClinicalTrials.gov ID
- NCT04405557
- Acronym / sponsor ID
- PREDICT
- Conditions
- Early Detection of Cancer
- Keywords
- Pan-cancer, cancer screening, ctDNA
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 757 participants (estimated)
- Lead sponsor
- Geneplus-Beijing Co. Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Chinese PLA General Hospital
- Study start
- 12 Nov 2019 (actual)
- Primary completion
- 16 Jan 2022 (actual)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 28 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.
This is a observational, multicenter study, monitoring the circulating tumor DNA (ctDNA) in people who is at risk of cancers，assessing the sensitivity and specificity of ctDNA detection in early screening of pan-carcinoma.
Detailed description
2000 patients with positive tumor protein markers or cancer screening were recruited. All patients were tested for ctDNA at enrollment and followed up at 6 months and 1 year. The study was completed at the time of cancer diagnosis or the longest follow-up time (1 year).
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- People with positive tumor protein marker or cancer screening.
Key inclusion criteria (18 listed)
- Patients aged at or over 45 years old.
- Patients who with one or more of the following situations:
- Ability to collect specimens from each time point and provide corresponding clinical information.
- Understand the research plan and voluntarily participate in the study, sign the informed consent form.
Key exclusion criteria (7 listed)
- Patients with previous or present cancer.
- Patients with serious diseases, especially those with a survival period of less than 3 years.
- Patients with factors that affect the diagnosis of the disease (such as MRI related cardiac pacemakers, ferromagnetic implants, etc.).
- Patients with a known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation.
- Women who are pregnant or preparing for pregnancy.
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
Analysis of ctDNA for early detection in cancer high-risk population.
Time frame: 1 year
To evaluate the sensitivity, specificity and positive predictive value of ctDNA for screening in high-risk population. Including the following six types of cancer: hepatocellular carcinoma, pancreatic cancer, ovarian cancer, breast cancer, colorectal cancer and gastric cancer.
1 secondary outcome
Window period from ctDNA positive to cancer diagnosis.
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2025.
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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.
Qiang Zeng, MD principal investigator
Chinese PLA General Hospital
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Early Detection of Cancer, run by Geneplus-Beijing Co. Ltd. at 8 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 18 inclusion and 7 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: under way, not looking for participants, as of the sponsor's last update on 4 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Analysis of ctDNA for early detection in cancer high-risk population. (time frame: 1 year). 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 4 Sep 2025.