Prospective Screening and Differentiating Common Cancers Using Peripheral Blood Cell-Free DNA Sequencing

May 15, 2024 updated by: Yanglin Pan, Air Force Military Medical University, China

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

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.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

3200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
      • Urumqi, China
        • Recruiting
        • Affiliated Cancer Hospital of Xinjiang Medical University
        • Contact:
          • Gang Sun, MD
        • Sub-Investigator:
          • Yan Wang, MD
    • Guangdong
      • Guangzhou, Guangdong, China, 510000
        • Recruiting
        • The First Affiliated Hospital of Guangzhou Medical University
        • Principal Investigator:
          • Wei Wang, MD
        • Contact:
          • Miao He, MD
          • Phone Number: 86-13527822580
        • Sub-Investigator:
          • Miao He
      • Guangzhou, Guangdong, China, 510000
        • Not yet recruiting
        • Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
        • Contact:
          • Fengxia Gan, PhD
          • Phone Number: 86-18810532592
        • Principal Investigator:
          • Yaping Yang, MD
        • Sub-Investigator:
          • Fengxia Gan, PhD
        • Sub-Investigator:
          • Changzhen Shang, MD
    • Liaoning
      • Shenyang, Liaoning, China, 110000
        • Not yet recruiting
        • First Hospital of China Medical University
        • Contact:
        • Principal Investigator:
          • Liping Sun, PhD
        • Sub-Investigator:
          • Yijun Wu, MM
    • Ningxia
      • Yinchuan, Ningxia, China, 750000
        • Not yet recruiting
        • People's Hospital of Ningxia Hui Autonomous Region
        • Contact:
    • Shaanxi
      • Xi'an, Shaanxi, China, 710032
        • Recruiting
        • First Affiliated Hospital of Air Force Military Medical University
        • Principal Investigator:
          • Yanglin Pan, MD
        • Contact:
        • Sub-Investigator:
          • Linan Zhao, MD
        • Sub-Investigator:
          • Fan Feng, MD
        • Sub-Investigator:
          • Yuanyuan Lu, MD
        • Sub-Investigator:
          • Huahong Xie, MD
      • Xi'an, Shaanxi, China, 710032
        • Recruiting
        • Tang-Du Hospital
        • Contact:
        • Principal Investigator:
          • Yunfeng Ni, MD
        • Sub-Investigator:
          • Xiaochen Liu, MM
    • Shandong
      • Liaocheng, Shandong, China, 252500
        • Recruiting
        • Guanxian People's Hospital
        • Contact:
          • Xinmeng Yang, BN
          • Phone Number: 86-18366490144
        • Principal Investigator:
          • Bailong Sheng, MM
        • Sub-Investigator:
          • Xinmeng Yang, BN

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Multicenter prospective cancer-screening cohort
The cohort, including cancer patients and non-cancer patients, will be prospectively enrolled in from different departments and centers. The focused cancers include lung cancer, gastric cancer, colorectal cancer, liver cancer, esophagus cancer, breast cancer and pancreas cancer.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
diagnostic accuracy
Time Frame: Immediately after test completion
This refers to the ability of the test (peripheral blood cell-free DNA sequencing) to correctly classify individuals into the categories of having or not having the disease. It is a measure of the test's overall effectiveness. The reference test is histological test for cancers or one-year follow-up for non-cancers.
Immediately after test completion
sensitivity
Time Frame: Immediately after test completion
This is the ability of the test (peripheral blood cell-free DNA sequencing) to correctly identify those with the disease. It is the proportion of true positive results (those with the disease who test positive) to the total number of individuals who actually have the disease. The reference test is histological test for cancers or one-year follow-up for non-cancers.
Immediately after test completion
specificity
Time Frame: Immediately after test completion
This is the ability of the test (peripheral blood cell-free DNA sequencing) to correctly identify those without disease. It is the proportion of true negative results (those without the disease who test negative) to the total number of individuals who actually do not have the disease. The reference test is histological test for cancers or one-year follow-up for non-cancers.
Immediately after test completion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Air Force Military Medical University, China

Collaborators

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
The First Affiliated Hospital of Guangzhou Medical University
Tang-Du Hospital
First Hospital of China Medical University
Xinjiang Medical University
People's Hospital of Ningxia Hui Autonomous Region
Guanxian People's Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2023

Primary Completion (Estimated)

August 1, 2025

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

September 7, 2023

First Submitted That Met QC Criteria

September 7, 2023

First Posted (Actual)

September 14, 2023

Study Record Updates

Last Update Posted (Actual)

May 16, 2024

Last Update Submitted That Met QC Criteria

May 15, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KY20232260-F-1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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