The PREDICT Study: Prospective Early Detection In a Population at High-risk for Common Malignant Tumor

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

757 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-11-12

Study Completion Date

2026-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Circulating Tumor DNA in Surgical Lung Cancer Patients

NCT03081741

Lung Neoplasms

UNKNOWN

ctDNA Dynamic Monitoring and Its Role of Prognosis in Stage I NSCLS by NGS

NCT03172156

Non-small Cell Lung Cancer Stage I

COMPLETED

Multiplex Analysis of Circulating Tumor DNA

NCT03301961

Carcinoma Non-small-cell Lung Cancer Lung Neoplasm

UNKNOWN

ctDNA-MRD in Stage IIIB-C NSCLC Patients Treated With Induction Chemoimmunotherapy

NCT05822284

Non-small Cell Lung Cancer

NOT_YET_RECRUITING

ctDNA Analysis to Monitor the Risk of Progression After First-line Immunotherapy in Patients With Advanced NSCLC

NCT05198154

Advanced Lung Non-Small Cell Carcinoma

RECRUITING

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Early Detection of Cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. Patients aged at or over 45 years old.
2. Patients who with one or more of the following situations:

1. 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.
2. Patients with viral hepatitis (Hepatitis B / C surface antigen positive with liver function damage.
3. Patients with liver nodules detected by ultrasound and hemangioma excluded.
4. Patients with compensated cirrhosis.
5. 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).
6. Patients with ovarian masses found by ultrasonography (premenopausal \> 5cm, postmenopausal \> 3.5cm).
7. Patients with pancreatic space-occupying found by ultrasonography.
8. Patients with BI-RADS grade 4 or above by ultrasound or mammography.
9. CA125\>35U/ml and BI-RADS above grade 3 by ultrasound or mammography.
10. CA153\>25U/ml and BI-RADS above grade 3 by ultrasound or mammography.
11. Family genetic history of breast cancer and ovarian cancer, and BI-RADS above grade 3 by ultrasound or mammography.
12. Patients with a positive fecal occult blood test and haemorrhoids excluded
13. Patients with a positive fecal occult blood test and positive CEA
14. 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).
3. Ability to collect specimens from each time point and provide corresponding clinical information.
4. Understand the research plan and voluntarily participate in the study, sign the informed consent form.

Exclusion Criteria

1. Patients with previous or present cancer.
2. Patients with serious diseases, especially those with a survival period of less than 3 years.
3. Patients with factors that affect the diagnosis of the disease (such as MRI related cardiac pacemakers, ferromagnetic implants, etc.).
4. Patients with a known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation.
5. Women who are pregnant or preparing for pregnancy.
6. Patients who voluntarily withdraw for any reason.
7. Patients who cannot complete the research plan

Minimum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No