Clinical trial NCT04405557: The PREDICT Study: Prospective Early Detection In a Population at High-risk for Common Malignant Tumor
Official title: Study on the Application of ctDNA in a Population at High-risk for Common Malignant Tumor
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Early Detection of Cancer
Keywords: Pan-cancer
cancer screening
ctDNA
Lead sponsor: Geneplus-Beijing Co. Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Chinese PLA General Hospital
First posted: 2020-05-28
Enrollment: 757
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: People with positive tumor protein marker or cancer screening.

Brief 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.

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).

Eligibility criteria: 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

Primary outcomes:
measure: Analysis of ctDNA for early detection in cancer high-risk population.
timeFrame: 1 year
Secondary outcomes:
measure: Window period from ctDNA positive to cancer diagnosis.
timeFrame: 1 year
Other outcomes:
Locations:
city: Beijing
country: China
facility: Chinese PLA General Hospital
state: Beijing
city: Shenzhen
country: China
facility: Shenzhen People's Hospital
state: Guangdong
city: Zhengzhou
country: China
facility: Henan Provincial People's Hospital
state: Henan
city: Changsha
country: China
facility: Xiangya Hospital Central South University
state: Hunan
city: Nanjing
country: China
facility: Jiangsu Province Hospital
state: Jiangsu
city: Changchun
country: China
facility: China-Japan Union Hospital of Jilin University
state: Jilin
city: Jinzhou
country: China
facility: The First Affiliated Hospital of Jinzhou Medical University
state: Liaoning
city: Chengdu
country: China
facility: Sichuan Provincial People's Hospital
state: Sichuan
Study officials:
affiliation: Chinese PLA General Hospital
name: Qiang Zeng, MD
role: PRINCIPAL_INVESTIGATOR
References: