Pancreas CancerPROJECTIONNCT04246203
Prognostic Role of Circulating Tumor DNA in Resectable Pancreatic Cancer
An observational study of Pancreas Cancer, run by Ludwig-Maximilians - University of Munich at 6 sites in Germany.
Trial summary
This is a non-randomized, multicenter, non-interventional study in patients with resectable PDAC. The patients are allocated to two observation groups according preoperative presence of ctDNA (Group A) or absence of detectable ctDNA (Group B) as determined in a liquid biopsy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreas Cancer
- What is being tested?
- Liquid Biopsy
- How many people
- 200 participants
- Where
- 6 sitesGermany
- Study dates
- 12 Dec 2021to 1 Dec 2026
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with pancreatic mass, suspicious of pancreatic cancer and deemed resectable will be prospectively enrolled in this observational study.
Who may be able to join
- Adult patients ≥ 18 years of age
- Pancreatic mass, suspicious of pancreatic cancer, deemed resectable and resection planned.
- Patient deemed medically fit for adjuvant chemotherapy by the investigator
- Patient's legal capacity to consent to study participation
- Signed and dated informed consent to participate in the study
Who cannot join
- Non-resectable disease as determined by a local tumor board
- Metastatic pancreatic disease
- Previous neoadjuvant chemotherapy
- Previous neoadjuvant radiotherapy
- Histology other than PDAC such as acinar, neuroendocrine, mixed histology etc. in the resection specimen
- Malignant disease other than PDAC within previous year (exception: patients with adequately treated and completely resected basal cell or squamous cell skin cancer; in situ cervical, breast or prostate cancer within previous year may be included)
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Germany6 sites
Charité - Universitätsmedizin Berlin
Berlin
Uniklinik Köln
Cologne
Universitätsklinikum Hamburg-Eppendorf
Hamburg
Ludwig Maximilians University Munich
Munich, Bavaria, 80799
Technische Universität München
Munich, 80333
Universitätsklinikum Ulm
Ulm
About this study
This is a non-randomized, multicenter, non-interventional study in patients with resectable PDAC. The patients are allocated to two observation groups according preoperative presence of ctDNA (Group A) or absence of detectable ctDNA (Group B) as determined in a liquid biopsy. After successful surgery of their pancreatic tumor and completion of local histological evaluation, tissue samples will be analyzed with regard to their mutational status with. Within 14 days before start of adjuvant tumor therapy another liquid biopsy will be taken to reassess the level of ctDNA after surgery.
Patients will be monitored for disease recurrence according to harmonized, institutional standards using clinical, laboratory and (cross-sectional) imaging modalities. Accordingly, patients will be assessed every three months in the first eighteen months after surgery and every six months thereafter or based on clinical need for 36 months after the date of surgery Follow up will be documented until occurrence of relapse (or death if death occurs earlier than relapse/progression) for a maximum of 36 months after the date of surgery.
- Conditions
- Pancreas Cancer
- Being tested
- Liquid Biopsy
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Liquid BiopsyOther
17-20 ml of blood will be collected prior of surgery and within 14 days before start of adjuvant chemotherapy.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Patients are allocated to group A according to preoperative presence of detectable ctDNA. Receives: Other: Liquid Biopsy | |
| Group B | Patients are allocated to group B according to preoperative absence of detectable ctDNA. Receives: Other: Liquid Biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
DFS
Comparison of disease-free survival (DFS) of patients with preoperative presence of ctDNA (Group A) and absence of ctDNA (Group B)
Measured: Follow up will be 36 months after surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2020
- Study start12 Dec 2021
- Primary completion1 Dec 2025 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreas CancerStudies 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
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ludwig-Maximilians - University of Munich
- Sponsor type
- University, hospital or other
- Collaborators
- Hoffmann-La Roche
- Responsible party
- Principal investigator, Benedikt Westphalen, Ludwig-Maximilians - University of Munich
- Investigators
- Benedikt Westphalen, Principal investigator, LMU Munich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04246203
- Sponsor's protocol ID
- ML40429
- Acronym
- PROJECTION
- Status last verified
- Mar 2025
- First submitted
- 26 Jan 2020
- Last updated
- 11 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prognostic Role of Circulating Tumor DNA in Resectable Pancreatic Cancer
- ClinicalTrials.gov ID
- NCT04246203
- Acronym / sponsor ID
- PROJECTION / ML40429
- Conditions
- Pancreas Cancer
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Ludwig-Maximilians - University of MunichUniversity, hospital or other
- Collaborators
- Hoffmann-La Roche
- Study start
- 12 Dec 2021 (actual)
- Primary completion
- 1 Dec 2025 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 29 Jan 2020 (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 non-randomized, multicenter, non-interventional study in patients with resectable PDAC. The patients are allocated to two observation groups according preoperative presence of ctDNA (Group A) or absence of detectable ctDNA (Group B) as determined in a liquid biopsy. After successful surgery of their pancreatic tumor and completion of local histological evaluation, tissue samples will be analyzed with regard to their mutational status with. Within 14 days before start of adjuvant tumor therapy another liquid biopsy will be taken to reassess the level of ctDNA after surgery.
Patients will be monitored for disease recurrence according to harmonized, institutional standards using clinical, laboratory and (cross-sectional) imaging modalities. Accordingly, patients will be assessed every three months in the first eighteen months after surgery and every six months thereafter or based on clinical need for 36 months after the date of surgery Follow up will be documented until occurrence of relapse (or death if death occurs earlier than relapse/progression) for a maximum of 36 months after the date of surgery.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | – | Other: Liquid BiopsyPatients are allocated to group A according to preoperative presence of detectable ctDNA. |
| Group B | – | Other: Liquid BiopsyPatients are allocated to group B according to preoperative absence of detectable ctDNA. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with pancreatic mass, suspicious of pancreatic cancer and deemed resectable will be prospectively enrolled in this observational study.
Key inclusion criteria (5 listed)
- Adult patients ≥ 18 years of age
- Pancreatic mass, suspicious of pancreatic cancer, deemed resectable and resection planned.
- Patient deemed medically fit for adjuvant chemotherapy by the investigator
- Patient's legal capacity to consent to study participation
- Signed and dated informed consent to participate in the study
Key exclusion criteria (6 listed)
- Non-resectable disease as determined by a local tumor board
- Metastatic pancreatic disease
- Previous neoadjuvant chemotherapy
- Previous neoadjuvant radiotherapy
- Histology other than PDAC such as acinar, neuroendocrine, mixed histology etc. in the resection specimen
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 |
|---|---|---|
| Liquid Biopsy17-20 ml of blood will be collected prior of surgery and within 14 days before start of adjuvant chemotherapy. | Other | Group A, Group B |
Primary outcome
DFS
Time frame: Follow up will be 36 months after surgery.
Comparison of disease-free survival (DFS) of patients with preoperative presence of ctDNA (Group A) and absence of ctDNA (Group B)
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 11 Mar 2025.
- Individual participant dataSharing planned: Undecided
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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.
Benedikt Westphalen principal investigator
LMU Munich
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pancreas Cancer, run by Ludwig-Maximilians - University of Munich at 6 sites in Germany.
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 5 inclusion and 6 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: under way, not looking for participants, as of the sponsor's last update on 11 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Germany. 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?
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?
DFS (time frame: Follow up will be 36 months after surgery.). 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 11 Mar 2025.