beta
Trial Radar AI
Clinical Trial NCT06036563 for Cancer Diagnosis, LungCancer, Gastric Cancer, Liver Cancer, Colorectal Cancer, Esophagus Cancer, Breast Cancer, Pancreas Cancer is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.
One study matched filter criteria
Card View
Back to Search

Prospective Screening and Differentiating Common Cancers Using Peripheral Blood Cell-Free DNA Sequencing 3,200 Observational

Recruiting
Clinical Trial NCT06036563 is an observational study for Cancer Diagnosis, LungCancer, Gastric Cancer, Liver Cancer, Colorectal Cancer, Esophagus Cancer, Breast Cancer, Pancreas Cancer that is recruiting. It started on 1 September 2023 with plans to enroll 3,200 participants. Led by Air Force Military Medical University, China, it is expected to complete by 1 December 2025. The latest data from ClinicalTrials.gov was last updated on 16 May 2024.
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 ...Show More
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

Conditions
Cancer DiagnosisLungCancerGastric CancerLiver CancerColorectal CancerEsophagus CancerBreast CancerPancreas Cancer
Publications
Scientific articles and research papers published about this clinical trial:
Other Study IDs
  • KY20232260-F-1
NCT ID Number
NCT06036563
Start Date (Actual)
2023-09-01
Last Update Posted
2024-05-16
Completion Date (Estimated)
2025-12
Enrollment (Estimated)
3,200
Study Type
Observational
Status
Recruiting
Keywords
multicancer screening
liquid biopsy
cell-free DNA
methylation
machine learning
Arms / Interventions
Participant Group/ArmIntervention/Treatment
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.
N/A
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
diagnostic accuracy
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
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
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
Participation Assistant
Eligibility Criteria

Eligible Ages
Adult, Older Adult
Minimum Age
20 Years
Eligible Sexes
All
Accepts Healthy Volunteers
Yes
  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.

  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.
Air Force Military Medical University, China logoAir Force Military Medical University, China
Study Responsible Party
Yanglin Pan, Principal Investigator, Professor, Air Force Military Medical University, China
Study Central Contact
Contact: Yanglin Pan, MD, 86-13991811225, [email protected]
8 Study Locations in 1 Countries

Guangdong

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University, Guangzhou, Guangdong, 510000, China
Fengxia Gan, PhD, Contact, 86-18810532592
Yaping Yang, MD, Principal Investigator
Fengxia Gan, PhD, Sub-Investigator
Changzhen Shang, MD, Sub-Investigator
Not yet recruiting
The First Affiliated Hospital of Guangzhou Medical University, Guangzhou, Guangdong, 510000, China
Miao He, MD, Contact, 86-13527822580
Wei Wang, MD, Principal Investigator
Miao He, Sub-Investigator
Recruiting

Liaoning

First Hospital of China Medical University, Shenyang, Liaoning, 110000, China
Liping Sun, PhD, Contact, 86-24-83282153, [email protected]
Liping Sun, PhD, Principal Investigator
Yijun Wu, MM, Sub-Investigator
Not yet recruiting

Ningxia

People's Hospital of Ningxia Hui Autonomous Region, Yinchuan, Ningxia, 750000, China
Shengjuan Hu, MD, Contact, [email protected]
Not yet recruiting

Shaanxi

First Affiliated Hospital of Air Force Military Medical University, Xi'an, Shaanxi, 710032, China
Yanglin Pan, MD, Contact, 13991811225, [email protected]
Yanglin Pan, MD, Principal Investigator
Linan Zhao, MD, Sub-Investigator
Fan Feng, MD, Sub-Investigator
Yuanyuan Lu, MD, Sub-Investigator
Huahong Xie, MD, Sub-Investigator
Recruiting
Tang-du Hospital, Xi'an, Shaanxi, 710032, China
Yunfeng Ni, MD, Contact, 86-13772088014, [email protected]
Yunfeng Ni, MD, Principal Investigator
Xiaochen Liu, MM, Sub-Investigator
Recruiting

Shandong

Guanxian People's Hospital, Liaocheng, Shandong, 252500, China
Xinmeng Yang, BN, Contact, 86-18366490144
Bailong Sheng, MM, Principal Investigator
Xinmeng Yang, BN, Sub-Investigator
Recruiting
Affiliated Cancer Hospital of Xinjiang Medical University, Ürümqi, China
Gang Sun, MD, Contact
Yan Wang, MD, Sub-Investigator
Recruiting