CancerTHUNDERNCT04820868
The Unintrusive Detection of EaRly-stage Cancers
An observational study of Cancer, run by Shanghai Zhongshan Hospital at 1 site in China.
Trial summary
According to a previous study, a cell-free DNA (cfDNA) methylation-based model showed high sensitivity and specificity (80.6% and 98.3%) in blood-based multi-cancer detection. In this way, a multi-center, prospective, single-blind study (THUNDER study) is designed to further validate the performance of the cfDNA… Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Cancer
- What is being tested?
- Multi-cancer early detection test
- Type of treatment
- Medical device
- How many people
- 2,508 participants
- Where
- 1 siteChina
- Study dates
- 23 Apr 2021to 30 Apr 2022
- 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 40 to 75 years
- All sexes
- Adult, Older adult
Study population: Eligible participants will be recruited from medical centers and assigned into two arms, including participants with new diagnosis of malignancies and healthy participants.
Who may be able to join
- Ability to provide a written informed consent
- 40-75 years old
- Ability to comply with study procedures
- Confirmed diagnosis or suspicious cases of cancer within 42 days prior to study blood draw.
- No prior anti-cancer therapy (local or systematic) prior to study blood draw
- No cancer-related symptoms or discomfort within 30 days prior to study blood draw
Show all 9Show fewer
- No clinically significant finding by physical examinations, hematological assessment, urinalysis, LDCT or ultrasound
- No clinically significant finding by breast ultrasound or Molybdenum Target Mammography Detection, or Thinprep cytologic test (TCT) detection for female participants
- No active hepatitis B or hepatitis C infection
Who cannot join
- Pregnancy or lactating women
- Recipients of organ transplant or prior non-autologous (allogeneic) bone marrow transplant or stem cell transplant
- Recipients of blood transfusion within 7 days prior to study blood draw
- Recipients of any anti-cancer therapy within 30 days prior to study blood draw, due to diseases other than cancer
- Known prior or current diagnosis of other types of malignancies or multiple primary tumors
- Diagnosis of benign diseases by histopathological assessments
Show all 11Show fewer
- No confirmed diagnosis of cancer by histopathological or radiological assessments within 42 days of study blood draw, or inability to characterize whether the lesion is malignant or benign
- Non-small-cell lung cancer patients with ground-class nodularity by radiological examination
- Diagnosis of precancerous lesions
- Prior or ongoing treatment of cancer within 3 years prior to study blood draw
- Clinically significant or uncontrolled comorbidities
Trial locations and contacts
1 site in 1 country.
China1 site
Zhongshan Hospital, Fudan University
Shanghai, Shanghai Municipality, 200032
About this study
Official title: A Blinded Prospective Study on Validation of the Performance of a cfDNA Methylation-based Model for Early Cancer Detection
According to a previous study, a cell-free DNA (cfDNA) methylation-based model showed high sensitivity and specificity (80.6% and 98.3%) in blood-based multi-cancer detection. In this way, a multi-center, prospective, single-blind study (THUNDER study) is designed to further validate the performance of the cfDNA methylation-based model for early cancer detection. Blood RNA markers will also be evaluated. The study will enroll approximately 2508 participants, including participants with malignancies and healthy participants.
- Conditions
- Cancer
- Being tested
- Multi-cancer early detection test
- Keywords
- Cancer, Liquid biopsy, Cell-free DNA (cfDNA), Early detection
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multi-cancer early detection testDevice
Blood collection and multi-cancer early detection test
| Study group | Role | What they receive |
|---|---|---|
| Cancer Arm | Participants with new diagnosis of cancer, from whom blood samples will be collected Receives: Device: Multi-cancer early detection test | |
| Healthy Arm | Participants without known presence of malignancies or benign diseases, from whom blood samples will be collected Receives: Device: Multi-cancer early detection test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity and specificity of early detection of 6 types of cancers and Tissue of origin (TOO) accuracy of a cfDNA methylation-based model
Measured: 7 months
Secondary outcomes (1)
Sensitivity, specificity and TOO accuracy of a cfDNA methylation-based model in different stages or pathological types of cancer
Measured: 7 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2021
- Study start23 Apr 2021
- Primary completion30 Nov 2021
- Study completion30 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by Shanghai Zhongshan HospitalThe sponsor's other registered studies.
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 2,508 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Zhongshan Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Guangzhou Burning Rock Dx Co., Ltd.
- Responsible party
- Sponsor
- Investigators
- Qiang Gao, M.D., Principal investigator, Shanghai Zhongshan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04820868
- Sponsor's protocol ID
- RSCD2020003
- Acronym
- THUNDER
- Status last verified
- Mar 2023
- First submitted
- 26 Mar 2021
- Last updated
- 16 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Blinded Prospective Study on Validation of the Performance of a cfDNA Methylation-based Model for Early Cancer Detection
- ClinicalTrials.gov ID
- NCT04820868
- Acronym / sponsor ID
- THUNDER / RSCD2020003
- Conditions
- Cancer
- Keywords
- Cancer, Liquid biopsy, Cell-free DNA (cfDNA), Early detection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,508 participants (actual)
- Lead sponsor
- Shanghai Zhongshan HospitalUniversity, hospital or other
- Collaborators
- Guangzhou Burning Rock Dx Co., Ltd.
- Study start
- 23 Apr 2021 (actual)
- Primary completion
- 30 Nov 2021 (actual)
- Study completion
- 30 Apr 2022 (actual)
- First posted
- 29 Mar 2021 (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.
According to a previous study, a cell-free DNA (cfDNA) methylation-based model showed high sensitivity and specificity (80.6% and 98.3%) in blood-based multi-cancer detection. In this way, a multi-center, prospective, single-blind study (THUNDER study) is designed to further validate the performance of the cfDNA methylation-based model for early cancer detection. Blood RNA markers will also be evaluated. The study will enroll approximately 2508 participants, including participants with malignancies and healthy participants.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cancer Arm | – | Device: Multi-cancer early detection testParticipants with new diagnosis of cancer, from whom blood samples will be collected |
| Healthy Arm | – | Device: Multi-cancer early detection testParticipants without known presence of malignancies or benign diseases, from whom blood samples will be collected |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Eligible participants will be recruited from medical centers and assigned into two arms, including participants with new diagnosis of malignancies and healthy participants.
Key inclusion criteria (9 listed)
- Ability to provide a written informed consent
- 40-75 years old
- Ability to comply with study procedures
- Confirmed diagnosis or suspicious cases of cancer within 42 days prior to study blood draw.
- No prior anti-cancer therapy (local or systematic) prior to study blood draw
Key exclusion criteria (11 listed)
- Pregnancy or lactating women
- Recipients of organ transplant or prior non-autologous (allogeneic) bone marrow transplant or stem cell transplant
- Recipients of blood transfusion within 7 days prior to study blood draw
- Recipients of any anti-cancer therapy within 30 days prior to study blood draw, due to diseases other than cancer
- Known prior or current diagnosis of other types of malignancies or multiple primary tumors
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multi-cancer early detection testBlood collection and multi-cancer early detection test | Device | Cancer Arm, Healthy Arm |
Primary outcome
Sensitivity and specificity of early detection of 6 types of cancers and Tissue of origin (TOO) accuracy of a cfDNA methylation-based model
Time frame: 7 months
1 secondary outcome
Sensitivity, specificity and TOO accuracy of a cfDNA methylation-based model in different stages or pathological types of cancer
Time frame: 7 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2023.
- Individual participant dataSharing planned: No
Related trials for Cancer
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
RecruitingPhase 2
Tafasitamab With Acalabrutinib and Venetoclax for the Treatment of Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Chronic Lymphocytic Leukemia, Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Active, not recruitingPhase 1/2
Selumetinib in Treating Young Patients With Recurrent or Refractory Low Grade Glioma
Low Grade Glioma, Recurrent Childhood Pilocytic Astrocytoma
Enrolling by invitationPhase 2
A Single-Arm Study of Nimotuzumab Combined With NALIRIFOX as First-Line Treatment for Pancreatic Cancer
Pancreatic Cancer Metastatic
Recruiting
Methylation Profiling in Self-Samples for Identification of (Epi)Genetic Biomarkers for Gynecological Cancers
Gynaecological Cancers, Ovarian Cancer
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.
Qiang Gao, M.D. principal investigator
Shanghai Zhongshan Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer, run by Shanghai Zhongshan Hospital at 1 site 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 9 inclusion and 11 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: finished, as of the sponsor's last update on 16 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity and specificity of early detection of 6 types of cancers and Tissue of origin (TOO) accuracy of a cfDNA methylation-based model (time frame: 7 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Mar 2023.