Pancreatic CancerNCT06166147
A Prospective Study of Liquid Biopsy for Pancreatic Cancer Early Detection
An observational study of Pancreatic Cancer, run by Fudan University at 3 sites in China.
Trial summary
This study is a multi-center, observational study aiming at developing a machine learning-based early detection model using prospectively collected liquid biopsy samples from clinically-annotated individuals. Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Pancreatic Cancer
- How many people
- 276 participants
- Where
- 3 sitesChina
- Study dates
- 18 Dec 2023to 31 Mar 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Adult, Older adult
Study population: Patients diagnosed pancreatic cancer or pancreatic non-malignant disease
Who may be able to join
- 40-75 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.
- 40-75 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 (e.g. severe or critical COVID-19, sepsis, etc.) or febrile illness (body temperature of ≥ 38.0 °C) 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
Show all 15Show fewer
- Other conditions that the investigators considered are not suitable for the enrollment
- Benign Disease Arm
- Pregnancy or lactating women
- Known prior or current diagnosis of other types of malignancies comorbidities
- Severe acute infection (e.g. severe or critical COVID-19, sepsis, etc.) or febrile illness (body temperature of ≥ 38.0 °C) 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
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Si Shi, M.D., Ph.D. contact
China3 sites, 3 recruiting
- Recruiting
Department of Pancreatic and Hepatobiliary Surgery, Fudan University Shanghai Cancer Center; Pancreatic Cancer Institute, Fudan University
Shanghai, Shanghai Municipality, 200032
Xian-Jun Yu, M.D., Ph.D., +86-21-6417-5590, yuxianjun@fudanpci.org
M.D., Ph.D.
- Recruiting
Department of Hepato-Biliary-Pancreatic-Splenic Surgery, Shanghai General Hospital
Shanghai, Shanghai Municipality, 200080
Jiang Long, M.D., Ph.D.
Jiang Long, M.D., Ph.D.
- Recruiting
Department of General Sugery, Huadong Hospital
Shanghai, Shanghai Municipality
Chong-Yi Jiang, M.D., Ph.D.
About this study
Official title: A Proof of Concept Study of Pancreatic Cancer Early Detection by cfDNA Assay
This study is a multi-center, observational study aiming at developing a machine learning-based early detection model using prospectively collected liquid biopsy samples from clinically-annotated individuals.
Read the detailed description
Peripheral blood samples from participants with new diagnosis of pancreatic cancers will be collected to characterize the cancer-specific circulating signals by sequencing cell free DNA. A noninvasive test integrating machine learning algorithm will be trained and validated through a two-stage approach in recruited well-classified individuals, along with non-cancers without clinical diagnosis of cancer after routine medical screening. The performance of liquid biospy assays discovering cancer from non-cancer will be evaluated in participants with benign disease as well as average risk individuals.
- Conditions
- Pancreatic Cancer
- Medical subject headings
- 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 |
|---|---|---|
| Cancer arm | Participants with new diagnosis of pancreatic cancer, from whom a peripheral blood sample will be collected. | |
| Benign disease arm | Participants with benign pancreatic diseases, from whom a peripheral blood sample will be collected. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Performance of cfDNA methylation-based model for discriminating pancreatic cancer versus non-cancer
Sensitivities of cfDNA methylation-based model at specificity of 99% and 95%, respectively.
Measured: 12 months
Secondary outcomes (2)
Performance of models using multi-omic data for discriminating pancreatic cancer versus non-cancer
Sensitivities of model integrating multi-omics data at specificity of 99% and 95%,respectively.
Measured: 12 months
Performance of pre-defined model in clinical sub-groups of interest
Sensitivity of pre-defined model in different pathological subtypes or different age groups or tumor marker-negative cases.
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 posted12 Dec 2023
- Study start18 Dec 2023
- Primary completion31 Oct 2026 (estimated)
- Study completion31 Mar 2027 (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
- 276 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Collaborators
- Shanghai Weihe Medical Laboratory Co., Ltd.
- Responsible party
- Principal investigator, Xian-Jun Yu, Fudan University
- Investigators
- Xian-Jun Yu, M.D., Ph.D., Study chair, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06166147
- Sponsor's protocol ID
- Profound-PC
- Status last verified
- Sep 2024
- First submitted
- 7 Nov 2023
- Last updated
- 19 Sep 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 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Proof of Concept Study of Pancreatic Cancer Early Detection by cfDNA Assay
- ClinicalTrials.gov ID
- NCT06166147
- Acronym / sponsor ID
- Profound-PC
- Conditions
- Pancreatic Cancer
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 276 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Collaborators
- Shanghai Weihe Medical Laboratory Co., Ltd.
- Study start
- 18 Dec 2023 (actual)
- Primary completion
- 31 Oct 2026 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 12 Dec 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.
This study is a multi-center, observational study aiming at developing a machine learning-based early detection model using prospectively collected liquid biopsy samples from clinically-annotated individuals.
Detailed description
Peripheral blood samples from participants with new diagnosis of pancreatic cancers will be collected to characterize the cancer-specific circulating signals by sequencing cell free DNA. A noninvasive test integrating machine learning algorithm will be trained and validated through a two-stage approach in recruited well-classified individuals, along with non-cancers without clinical diagnosis of cancer after routine medical screening. The performance of liquid biospy assays discovering cancer from non-cancer will be evaluated in participants with benign disease as well as average risk individuals.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cancer arm | – | –Participants with new diagnosis of pancreatic cancer, from whom a peripheral blood sample will be collected. |
| Benign disease arm | – | –Participants with benign pancreatic diseases, from whom a peripheral blood sample will be collected. |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients diagnosed pancreatic cancer or pancreatic non-malignant disease
Key inclusion criteria (8 listed)
- 40-75 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.
- 40-75 years old
Key exclusion criteria (15 listed)
- Pregnancy or lactating women
- Known prior or current diagnosis of other types of malignancies comorbidities
- Severe acute infection (e.g. severe or critical COVID-19, sepsis, etc.) or febrile illness (body temperature of ≥ 38.0 °C) 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.
Primary outcome
Performance of cfDNA methylation-based model for discriminating pancreatic cancer versus non-cancer
Time frame: 12 months
Sensitivities of cfDNA methylation-based model at specificity of 99% and 95%, respectively.
2 secondary outcomes
Performance of models using multi-omic data for discriminating pancreatic cancer versus non-cancer
Time frame: 12 months
Performance of pre-defined model in clinical sub-groups of interest
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 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.
Si Shi, M.D., Ph.D. contact
Xian-Jun Yu, M.D., Ph.D. study chair
Fudan University
3 sites 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 3 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 8 inclusion and 15 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: looking for participants now, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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?
This study is still under way. Results are not available in the source record yet.
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 methylation-based model for discriminating pancreatic cancer versus non-cancer (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 19 Sep 2024.