Clinical trial NCT06036563: Prospective Screening and Differentiating Common Cancers Using Peripheral Blood Cell-Free DNA Sequencing
Official title: A Multicenter Prospective Diagnostic Test: Screening and Differentiating Common Cancers (Cancers of Lung, Stomach, Colorectum, Esophagus, Liver, Breast and Pancreas) Based on Peripheral Blood Cell-Free DNA Sequencing
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cancer Diagnosis
LungCancer
Gastric Cancer
Liver Cancer
Colorectal Cancer
Esophagus Cancer
Breast Cancer
Pancreas Cancer
Keywords: multicancer screening
liquid biopsy
cell-free DNA
methylation
machine learning
Lead sponsor: Air Force Military Medical University, China
Sponsor class: OTHER
Collaborators: name: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
name: Tang-Du Hospital
name: The First Affiliated Hospital of Guangzhou Medical University
name: First Hospital of China Medical University
name: People's Hospital of Ningxia Hui Autonomous Region
name: Xinjiang Medical University
name: Guanxian People's Hospital
First posted: 2023-09-14
Enrollment: 3200
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: PASS 21.0 is used to calculate the sample size for diagnostic tests. Based on the specificity and sensitivity of different cancer diagnoses in current and reported studies, the specificity is preset at 98%, and the sensitivity is preset at 75%. A two-sided test is chosen, with a confidence level of 1-α=0.9, and a confidence interval width of 10%. The minimum sample size for the diagnostic test is calculated as follows: each type of cancer should have no less than 202 cases in the diagnostic test, and the total number of cancer subjects should not be less than 1414. The ratio of cancer subjects to non-cancer subjects is set at 1:1. Considering the possibility of loss to follow-up, unqualified sample quality, and dropout during the study, the sample size for this study is preset at 3200.

Brief summary: The goal of this observational study is to screen and differentiate common cancers in participants with or without suspicious lesions. The main question the investigators aim to answer is: Can the developed model, using peripheral blood cell-free DNA sequencing, work well in screening and classifying common cancers especially in the early stages? Participants will undergo the collection of 15\~20ml of blood and 1\~2 telephone follow-up calls.


Eligibility criteria: Inclusion Criteria:

1. \>20 and \< 80 years old.
2. Cancer group: Newly diagnosed cancer patients with a confirmed pathological diagnosis within 90 days before blood collection or within 30 days after blood collection, including lung cancer, esophageal cancer, breast cancer, stomach cancer, colorectal cancer, liver cancer, and pancreatic cancer.

Non-cancer group: Individuals who have not been diagnosed with cancer during routine physical examinations and one-year follow-up.

Exclusion Criteria:

1. Uncontrolled or active systemic diseases, such as autoimmune diseases, tuberculosis, AIDS, etc.
2. New onset, recurrence, or exacerbation of various inflammations within 2 weeks before blood collection, or the presence of fever, use of corticosteroids.
3. New onset or exacerbation of thromboembolic diseases, hemorrhagic diseases, or those who have received allogeneic blood transfusion within 1 month before blood collection.
4. Any cancer treatment performed within the past 3 years.
5. Individuals who have undergone organ or bone marrow transplantation.
6. Participants during pregnancy or lactation.
7. Individuals with malnutrition, severe mental illness, or genetic diseases.
8. Other diseases or conditions deemed by the physician as unsuitable for participation in this study.
9. Individuals who are unable to sign an informed consent form.

Primary outcomes:
measure: diagnostic accuracy
timeFrame: Immediately after test completion
measure: sensitivity
timeFrame: Immediately after test completion
measure: specificity
timeFrame: Immediately after test completion
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
state: Guangdong
city: Guangzhou
country: China
facility: The First Affiliated Hospital of Guangzhou Medical University
state: Guangdong
city: Shenyang
country: China
facility: First Hospital of China Medical University
state: Liaoning
city: Yinchuan
country: China
facility: People's Hospital of Ningxia Hui Autonomous Region
state: Ningxia
city: Xi'an
country: China
facility: First Affiliated Hospital of Air Force Military Medical University
state: Shaanxi
city: Xi'an
country: China
facility: Tang-du Hospital
state: Shaanxi
city: Liaocheng
country: China
facility: Guanxian People's Hospital
state: Shandong
city: Urumqi
country: China
facility: Affiliated Cancer Hospital of Xinjiang Medical University
Study officials:
References:
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