Pancreatic CancerNCT06456281
Multi-omics Model for Pancreatic Cancer Screening Using cfDNA
An observational study of Pancreatic Cancer, run by Fudan University at 1 site in China.
Trial summary
This is a prospective case-control study, aiming at developing a cell free DNA (cfDNA) multi-omics precise diagnostic model for screening of pancreatic cancer. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Pancreatic Cancer
- What is being tested?
- A noninvasive cfDNA multi-omics assay
- How many people
- 480 participants
- Where
- 1 siteChina
- Study dates
- 28 Jun 2024to 30 Dec 2025
- 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 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients diagnosed pancreatic cancer or precancerous lesions and healthy individuals.
Who may be able to join
- 18-75 years old
- Clinically and/or pathologically diagnosed pancreatic cancer
- No prior or undergoing any systemic or local antitumor therapy, including but not limited to surgical resection, radiochemotherapy, endocrinotherapy, targeted therapy, immunotherapy, interventional therapy, etc.
- Able to provide a written informed consent and willing to comply with all part of the protocol procedures
- Physical status score ECOG 0-1
- 18-75 years old
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- Diagnosed with pancreatic intraepithelial tumor pancreatic intraepithelial lesions (PanINs), Intraductal papillary mucinous neoplasms (IPMN) or mucinous cystic neoplasms (MCN) by radiographical assess
- No prior or undergoing any systemic or local antitumor therapy, including but not limited to surgical resection, radiochemotherapy, endocrinotherapy, targeted therapy, immunotherapy, interventional therapy, etc.
- Able to provide a written informed consent and willing to comply with all part of the protocol procedures
- 18-75 years old
- Clinically and/or pathologically diagnosed pancreatic non-malignant disease (pancreatic intraepithelial neoplasia, pancreatic cyst and chronic pancreatitis)
- No prior or undergoing any systemic or local antitumor therapy, including but not limited to surgical resection, radiochemotherapy, endocrinotherapy, targeted therapy, immunotherapy, interventional therapy, etc.
- Able to provide a written informed consent and willing to comply with all part of the protocol procedures
Who cannot join
- Pregnancy or lactating women
- Known prior or current diagnosis of other types of malignancies comorbidities
- Severe acute infection or febrile illness within 14 days prior to blood draw
- Recipients of organ transplant or prior bone marrow transplant or stem cell transplant
- Recipients of blood transfusion within 30 days prior to study blood draw
- Recipients of therapy in past 14 days prior to blood draw, including oral or IV antibiotics, glucocorticoid, azacitidine, decitabine, procainamine, hydrazine, arsenic trioxide
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- Other conditions that the investigators considered are not suitable for the enrollment
- Precancerous Lesions Arm
- Pregnancy or lactating women
- Known prior or current diagnosis of other types of malignancies comorbidities
- Severe acute infection or febrile illness within 14 days prior to blood draw
- Recipients of organ transplant or prior bone marrow transplant or stem cell transplant
- Recipients of blood transfusion within 30 days prior to study blood draw
- Recipients of therapy in past 14 days prior to blood draw, including oral or IV antibiotics, glucocorticoid, azacitidine, decitabine, procainamine, hydrazine, arsenic trioxide
- Other conditions that the investigators considered are not suitable for the enrollment
- Healthy Individuals Arm
- Pregnancy or lactating women
- Known prior or current diagnosis of other types of malignancies comorbidities
- Severe acute infection or febrile illness within 14 days prior to blood draw
- Recipients of organ transplant or prior bone marrow transplant or stem cell transplant
- Recipients of blood transfusion within 30 days prior to study blood draw
- Recipients of therapy in past 14 days prior to blood draw, including oral or IV antibiotics, glucocorticoid, azacitidine, decitabine, procainamine, hydrazine, arsenic trioxide
- Other conditions that the investigators considered are not suitable for the enrollment
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Department of Pancreatic and Hepatobiliary Surgery, Fudan University Shanghai Cancer Center; Pancreatic Cancer Institute, Fudan University; 270 Dong An Road, Shanghai 200032, China
Shanghai, Shanghai Municipality, 200032
Xian-Jun Yu, M.D., Ph.D., +86-21-64175590, yuxianjun@fudanpci.org
Xian-Jun Yu, M.D., Ph.D.
About this study
Official title: Development and Validation of Multi-omics Model for Screening of Pancreatic Cancer Using cfDNA
This is a prospective case-control study, aiming at developing a cell free DNA (cfDNA) multi-omics precise diagnostic model for screening of pancreatic cancer.
Read the detailed description
Peripheral blood samples from participants with new diagnosis of pancreatic cancers, precancerous lesions and healthy individuals will be collected to characterize the cancer-specific signatures by low-pass whole-genome sequencing and target methylation sequencing using cfDNA. An ensemble multi-omics model will be trained aided by machine learning algorithm and validated in test set. The performance of this multi-omics model distinguishing pancreatic cancer from non-cancer will be evaluated.
- Conditions
- Pancreatic Cancer
- Being tested
- A noninvasive cfDNA multi-omics assay
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A noninvasive cfDNA multi-omics assayDiagnostic test
Peripheral venous blood samples will be collected from pancreatic cancer patients, individuals with precancerous lesions, and healthy controls. Subsequently, cfDNA will be extracted and subjected to low-pass whole genome sequencing (LP-WGS) and hybrid capture-based targeted methylation sequencing (TMS).
| Study group | Role | What they receive |
|---|---|---|
| Cancer arm | Participants with new diagnosis of pancreatic cancer. Receives: Diagnostic Test: A noninvasive cfDNA multi-omics assay | |
| Precancerous lesions arm | Participants with precancerous lesions. Receives: Diagnostic Test: A noninvasive cfDNA multi-omics assay | |
| Healthy individuals arm | Healthy individuals without findings of clinical significance during routine health checkups. Receives: Diagnostic Test: A noninvasive cfDNA multi-omics assay |
What is being measured
The primary outcome is the main question the study is designed to answer.
Performance of cfDNA multi-omics model for discriminating pancreatic cancer versus healthy individuals.
The area under the curve (AUC), sensitivity and specificity of cfDNA multi-omics model.
Measured: 12 months
Secondary outcomes (3)
Performance of cfDNA multi-omics model for discriminating patients with pancreatic cancer and precancerous lesions versus healthy individuals.
Sensitivity of cfDNA multi-omics model at specificity of 95% for discriminating patients with pancreatic cancer and precancerous lesions versus healthy individuals.
Measured: 12 months
Performance of cfDNA multi-omics model for discriminating precancerous lesions versus healthy individuals.
Sensitivity of cfDNA multi-omics model for discriminating precancerous lesions versus healthy individuals.
Measured: 12 months
Performance of pre-defined model in clinical sub-groups of interest.
Sensitivity of cfDNA multi-omics model for pancreatic cancer at different stages or in different pathological subtypes.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2024
- Study start28 Jun 2024
- Primary completion30 Mar 2025 (estimated)
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic CancerStudies of the same condition, open and under way.
- More trials run by Fudan UniversityThe 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
- 480 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Collaborators
- Nanjing Simcere Medical Laboratory Science Co., Ltd.
- Responsible party
- Principal investigator, Xian-Jun Yu, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06456281
- Sponsor's protocol ID
- P04UR086-PAAD
- Status last verified
- Jun 2024
- First submitted
- 7 Jun 2024
- Last updated
- 1 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- 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 1 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Validation of Multi-omics Model for Screening of Pancreatic Cancer Using cfDNA
- ClinicalTrials.gov ID
- NCT06456281
- Acronym / sponsor ID
- P04UR086-PAAD
- Conditions
- Pancreatic Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 480 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Collaborators
- Nanjing Simcere Medical Laboratory Science Co., Ltd.
- Study start
- 28 Jun 2024 (actual)
- Primary completion
- 30 Mar 2025 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 13 Jun 2024 (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.
This is a prospective case-control study, aiming at developing a cell free DNA (cfDNA) multi-omics precise diagnostic model for screening of pancreatic cancer.
Detailed description
Peripheral blood samples from participants with new diagnosis of pancreatic cancers, precancerous lesions and healthy individuals will be collected to characterize the cancer-specific signatures by low-pass whole-genome sequencing and target methylation sequencing using cfDNA. An ensemble multi-omics model will be trained aided by machine learning algorithm and validated in test set. The performance of this multi-omics model distinguishing pancreatic cancer from non-cancer will be evaluated.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cancer arm | – | Diagnostic Test: A noninvasive cfDNA multi-omics assayParticipants with new diagnosis of pancreatic cancer. |
| Precancerous lesions arm | – | Diagnostic Test: A noninvasive cfDNA multi-omics assayParticipants with precancerous lesions. |
| Healthy individuals arm | – | Diagnostic Test: A noninvasive cfDNA multi-omics assayHealthy individuals without findings of clinical significance during routine health checkups. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients diagnosed pancreatic cancer or precancerous lesions and healthy individuals.
Key inclusion criteria (13 listed)
- 18-75 years old
- Clinically and/or pathologically diagnosed pancreatic cancer
- No prior or undergoing any systemic or local antitumor therapy, including but not limited to surgical resection, radiochemotherapy, endocrinotherapy, targeted therapy, immunotherapy, interventional therapy, etc.
- Able to provide a written informed consent and willing to comply with all part of the protocol procedures
- Physical status score ECOG 0-1
Key exclusion criteria (23 listed)
- Pregnancy or lactating women
- Known prior or current diagnosis of other types of malignancies comorbidities
- Severe acute infection or febrile illness within 14 days prior to blood draw
- Recipients of organ transplant or prior bone marrow transplant or stem cell transplant
- Recipients of blood transfusion within 30 days prior to study blood draw
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 |
|---|---|---|
| A noninvasive cfDNA multi-omics assayPeripheral venous blood samples will be collected from pancreatic cancer patients, individuals with precancerous lesions, and healthy controls. Subsequently, cfDNA will be extracted and subjected to low-pass whole genome sequencing (LP-WGS) and hybrid capture-based targeted methylation sequencing (TMS). | Diagnostic test | Cancer arm, Healthy individuals arm, Precancerous lesions arm |
Primary outcome
Performance of cfDNA multi-omics model for discriminating pancreatic cancer versus healthy individuals.
Time frame: 12 months
The area under the curve (AUC), sensitivity and specificity of cfDNA multi-omics model.
3 secondary outcomes
Performance of cfDNA multi-omics model for discriminating patients with pancreatic cancer and precancerous lesions versus healthy individuals.
Time frame: 12 months
Performance of cfDNA multi-omics model for discriminating precancerous lesions versus healthy individuals.
Time frame: 12 months
Performance of pre-defined model in clinical sub-groups of interest.
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2024.
- 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.
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 Pancreatic Cancer, run by Fudan University 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 13 inclusion and 23 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 1 Jul 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xian-Jun Yu, M.D., Ph.D. (+86-21-64175590, yuxianjun@fudanpci.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Performance of cfDNA multi-omics model for discriminating pancreatic cancer versus healthy individuals. (time frame: 12 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 1 Jul 2024.