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

  • STATUS
    Recruiting
  • participants needed
    2000
  • sponsor
    Geneplus-Beijing Co. Ltd.
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Updated on 19 February 2024
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Summary

This is a observational, multicenter study, monitoring the circulating tumor DNA (ctDNA) in people who is at risk of cancersassessing the sensitivity and specificity of ctDNA detection in early screening of pan-carcinoma.

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).

Details
Condition cancer screening
Age 45years - 100years
Clinical Study IdentifierNCT04405557
SponsorGeneplus-Beijing Co. Ltd.
Last Modified on19 February 2024

Eligibility

 Yes No Not Sure

Inclusion Criteria

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
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: PGI70 UG/L, PGR7.0, G-171 pmol/L or G-1715 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

Exclusion Criteria

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
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