Cancer DiagnosisNCT06036563
Prospective Screening and Differentiating Common Cancers Using Peripheral Blood Cell-Free DNA Sequencing
An observational study of Cancer Diagnosis and LungCancer, run by Air Force Military Medical University, China at 8 sites in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 20 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Cancer Diagnosis, LungCancer, Gastric Cancer
- How many people
- 3,200 participants
- Where
- 8 sitesChina
- Study dates
- 1 Sep 2023to Dec 2025
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- >20 and < 80 years old.
- 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.
Who cannot join
- Uncontrolled or active systemic diseases, such as autoimmune diseases, tuberculosis, AIDS, etc.
- New onset, recurrence, or exacerbation of various inflammations within 2 weeks before blood collection, or the presence of fever, use of corticosteroids.
- New onset or exacerbation of thromboembolic diseases, hemorrhagic diseases, or those who have received allogeneic blood transfusion within 1 month before blood collection.
- Any cancer treatment performed within the past 3 years.
- Individuals who have undergone organ or bone marrow transplantation.
- Participants during pregnancy or lactation.
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- Individuals with malnutrition, severe mental illness, or genetic diseases.
- Other diseases or conditions deemed by the physician as unsuitable for participation in this study.
- Individuals who are unable to sign an informed consent form.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
China8 sites, 8 recruiting
- Not yet recruiting
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Guangzhou, Guangdong, 510000
Fengxia Gan, PhD, 86-18810532592
Yaping Yang, MD
- Recruiting
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, 510000
Miao He, MD, 86-13527822580
Wei Wang, MD
- Recruiting
Guanxian People's Hospital
Liaocheng, Shandong, 252500
Xinmeng Yang, BN, 86-18366490144
Bailong Sheng, MM
- Not yet recruiting
First Hospital of China Medical University
Shenyang, Liaoning, 110000
Liping Sun, PhD, 86-24-83282153, lpsun@cmu.edu.cn
Liping Sun, PhD
- Recruiting
Affiliated Cancer Hospital of Xinjiang Medical University
Ürümqi
Gang Sun, MD
Yan Wang, MD
- Recruiting
First Affiliated Hospital of Air Force Military Medical University
Xi'an, Shaanxi, 710032
Yanglin Pan, MD, 13991811225, panyl@fmmu.edu.cn
Yanglin Pan, MD
- Recruiting
Tang-du Hospital
Xi'an, Shaanxi, 710032
Yunfeng Ni, MD, 86-13772088014, niyunfng@fmmu.edu.cn
Yunfeng Ni, MD
- Not yet recruiting
People's Hospital of Ningxia Hui Autonomous Region
Yinchuan, Ningxia, 750000
Shengjuan Hu, MD, hsj.judy@163.com
About this study
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
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.
- Conditions
- Cancer Diagnosis, LungCancer, Gastric Cancer, Liver Cancer, Colorectal Cancer, Esophagus Cancer
- Keywords
- multicancer screening, liquid biopsy, cell-free DNA, methylation, machine learning
- Medical subject headings
- Stomach Neoplasms, Liver Neoplasms, Colorectal Neoplasms, Esophageal Neoplasms, Breast Neoplasms, Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Immediately after test completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2023
- Study start1 Sep 2023
- Primary completionAug 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Cancer DiagnosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 3,200 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Air Force Military Medical University, China
- Sponsor type
- University, hospital or other
- Collaborators
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University, Tang-Du Hospital, The First Affiliated Hospital of Guangzhou Medical University, First Hospital of China Medical University, People's Hospital of Ningxia Hui Autonomous Region, Xinjiang Medical University, Guanxian County People's Hospital
- Responsible party
- Principal investigator, Yanglin Pan, Air Force Military Medical University, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06036563
- Sponsor's protocol ID
- KY20232260-F-1
- Status last verified
- May 2024
- First submitted
- 7 Sep 2023
- Last updated
- 16 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Nikanjam M, Kato S, Kurzrock R. Liquid biopsy: current technology and clinical applications. J Hematol Oncol. 2022 Sep 12;15(1):131. doi: 10.1186/s13045-022-01351-y.
PubMed 36096847Gao Q, Lin YP, Li BS, Wang GQ, Dong LQ, Shen BY, Lou WH, Wu WC, Ge D, Zhu QL, Xu Y, Xu JM, Chang WJ, Lan P, Zhou PH, He MJ, Qiao GB, Chuai SK, Zang RY, Shi TY, Tan LJ, Yin J, Zeng Q, Su XF, Wang ZD, Zhao XQ, Nian WQ, Zhang S, Zhou J, Cai SL, Zhang ZH, Fan J. Unintrusive multi-cancer detection by circulating cell-free DNA methylation sequencing (THUNDER): development and independent validation studies. Ann Oncol. 2023 May;34(5):486-495. doi: 10.1016/j.annonc.2023.02.010. Epub 2023 Feb 26.
PubMed 36849097Jamshidi A, Liu MC, Klein EA, Venn O, Hubbell E, Beausang JF, Gross S, Melton C, Fields AP, Liu Q, Zhang N, Fung ET, Kurtzman KN, Amini H, Betts C, Civello D, Freese P, Calef R, Davydov K, Fayzullina S, Hou C, Jiang R, Jung B, Tang S, Demas V, Newman J, Sakarya O, Scott E, Shenoy A, Shojaee S, Steffen KK, Nicula V, Chien TC, Bagaria S, Hunkapiller N, Desai M, Dong Z, Richards DA, Yeatman TJ, Cohn AL, Thiel DD, Berry DA, Tummala MK, McIntyre K, Sekeres MA, Bryce A, Aravanis AM, Seiden MV, Swanton C. Evaluation of cell-free DNA approaches for multi-cancer early detection. Cancer Cell. 2022 Dec 12;40(12):1537-1549.e12. doi: 10.1016/j.ccell.2022.10.022. Epub 2022 Nov 17.
PubMed 36400018Helzer KT, Sharifi MN, Sperger JM, Shi Y, Annala M, Bootsma ML, Reese SR, Taylor A, Kaufmann KR, Krause HK, Schehr JL, Sethakorn N, Kosoff D, Kyriakopoulos C, Burkard ME, Rydzewski NR, Yu M, Harari PM, Bassetti M, Blitzer G, Floberg J, Sjostrom M, Quigley DA, Dehm SM, Armstrong AJ, Beltran H, McKay RR, Feng FY, O'Regan R, Wisinski KB, Emamekhoo H, Wyatt AW, Lang JM, Zhao SG. Fragmentomic analysis of circulating tumor DNA-targeted cancer panels. Ann Oncol. 2023 Sep;34(9):813-825. doi: 10.1016/j.annonc.2023.06.001. Epub 2023 Jun 16.
PubMed 37330052Fan R, Chen L, Zhao S, Yang H, Li Z, Qian Y, Ma H, Liu X, Wang C, Liang X, Bai J, Xie J, Fan X, Xie Q, Hao X, Wang C, Yang S, Gao Y, Bai H, Dou X, Liu J, Wu L, Jiang G, Xia Q, Zheng D, Rao H, Xia J, Shang J, Gao P, Xie D, Yu Y, Yang Y, Gao H, Liu Y, Sun A, Jiang Y, Yu Y, Niu J, Sun J, Wang H, Hou J. Novel, high accuracy models for hepatocellular carcinoma prediction based on longitudinal data and cell-free DNA signatures. J Hepatol. 2023 Oct;79(4):933-944. doi: 10.1016/j.jhep.2023.05.039. Epub 2023 Jun 10.
PubMed 37302583
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06036563
- Acronym / sponsor ID
- KY20232260-F-1
- Conditions
- Cancer Diagnosis, LungCancer, Gastric Cancer, Liver Cancer, Colorectal Cancer, Esophagus Cancer
- Keywords
- multicancer screening, liquid biopsy, cell-free DNA, methylation, machine learning
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 3,200 participants (estimated)
- Lead sponsor
- Air Force Military Medical University, ChinaUniversity, hospital or other
- Collaborators
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University, Tang-Du Hospital, The First Affiliated Hospital of Guangzhou Medical University, First Hospital of China Medical University, People's Hospital of Ningxia Hui Autonomous Region, Xinjiang Medical University, Guanxian County People's Hospital
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- Aug 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 14 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- >20 and < 80 years old.
- 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.
Key exclusion criteria (9 listed)
- Uncontrolled or active systemic diseases, such as autoimmune diseases, tuberculosis, AIDS, etc.
- New onset, recurrence, or exacerbation of various inflammations within 2 weeks before blood collection, or the presence of fever, use of corticosteroids.
- New onset or exacerbation of thromboembolic diseases, hemorrhagic diseases, or those who have received allogeneic blood transfusion within 1 month before blood collection.
- Any cancer treatment performed within the past 3 years.
- Individuals who have undergone organ or bone marrow transplantation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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.
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2024.
- Background: PubMed 36096847Nikanjam M, Kato S, Kurzrock R. Liquid biopsy: current technology and clinical applications. J Hematol Oncol. 2022 Sep 12;15(1):131. doi: 10.1186/s13045-022-01351-y.
- Background: PubMed 36849097Gao Q, Lin YP, Li BS, Wang GQ, Dong LQ, Shen BY, Lou WH, Wu WC, Ge D, Zhu QL, Xu Y, Xu JM, Chang WJ, Lan P, Zhou PH, He MJ, Qiao GB, Chuai SK, Zang RY, Shi TY, Tan LJ, Yin J, Zeng Q, Su XF, Wang ZD, Zhao XQ, Nian WQ, Zhang S, Zhou J, Cai SL, Zhang ZH, Fan J. Unintrusive multi-cancer detection by circulating cell-free DNA methylation sequencing (THUNDER): development and independent validation studies. Ann Oncol. 2023 May;34(5):486-495. doi: 10.1016/j.annonc.2023.02.010. Epub 2023 Feb 26.
- Background: PubMed 36400018Jamshidi A, Liu MC, Klein EA, Venn O, Hubbell E, Beausang JF, Gross S, Melton C, Fields AP, Liu Q, Zhang N, Fung ET, Kurtzman KN, Amini H, Betts C, Civello D, Freese P, Calef R, Davydov K, Fayzullina S, Hou C, Jiang R, Jung B, Tang S, Demas V, Newman J, Sakarya O, Scott E, Shenoy A, Shojaee S, Steffen KK, Nicula V, Chien TC, Bagaria S, Hunkapiller N, Desai M, Dong Z, Richards DA, Yeatman TJ, Cohn AL, Thiel DD, Berry DA, Tummala MK, McIntyre K, Sekeres MA, Bryce A, Aravanis AM, Seiden MV, Swanton C. Evaluation of cell-free DNA approaches for multi-cancer early detection. Cancer Cell. 2022 Dec 12;40(12):1537-1549.e12. doi: 10.1016/j.ccell.2022.10.022. Epub 2022 Nov 17.
- Background: PubMed 37330052Helzer KT, Sharifi MN, Sperger JM, Shi Y, Annala M, Bootsma ML, Reese SR, Taylor A, Kaufmann KR, Krause HK, Schehr JL, Sethakorn N, Kosoff D, Kyriakopoulos C, Burkard ME, Rydzewski NR, Yu M, Harari PM, Bassetti M, Blitzer G, Floberg J, Sjostrom M, Quigley DA, Dehm SM, Armstrong AJ, Beltran H, McKay RR, Feng FY, O'Regan R, Wisinski KB, Emamekhoo H, Wyatt AW, Lang JM, Zhao SG. Fragmentomic analysis of circulating tumor DNA-targeted cancer panels. Ann Oncol. 2023 Sep;34(9):813-825. doi: 10.1016/j.annonc.2023.06.001. Epub 2023 Jun 16.
- Background: PubMed 37302583Fan R, Chen L, Zhao S, Yang H, Li Z, Qian Y, Ma H, Liu X, Wang C, Liang X, Bai J, Xie J, Fan X, Xie Q, Hao X, Wang C, Yang S, Gao Y, Bai H, Dou X, Liu J, Wu L, Jiang G, Xia Q, Zheng D, Rao H, Xia J, Shang J, Gao P, Xie D, Yu Y, Yang Y, Gao H, Liu Y, Sun A, Jiang Y, Yu Y, Niu J, Sun J, Wang H, Hou J. Novel, high accuracy models for hepatocellular carcinoma prediction based on longitudinal data and cell-free DNA signatures. J Hepatol. 2023 Oct;79(4):933-944. doi: 10.1016/j.jhep.2023.05.039. Epub 2023 Jun 10.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer Diagnosis and LungCancer, run by Air Force Military Medical University, China at 8 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yanglin Pan, MD (86-13991811225, yanglinpan@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
diagnostic accuracy (time frame: Immediately after test completion). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06036563, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2024.