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Prognostic Role of Circulating Tumor DNA in Resectable Pancreatic Cancer (PROJECTION)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04246203
Recruitment Status : Recruiting
First Posted : January 29, 2020
Last Update Posted : April 6, 2022
Sponsor:
Collaborator:
Hoffmann-La Roche
Information provided by (Responsible Party):
Benedikt Westphalen, Ludwig-Maximilians - University of Munich

Study Description
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Brief 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. 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.


Condition or disease Intervention/treatment
Pancreas Cancer Other: Liquid Biopsy

Study Design
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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prognostic Role of Circulating Tumor DNA in Resectable Pancreatic Cancer
Actual Study Start Date : December 12, 2021
Estimated Primary Completion Date : March 1, 2024
Estimated Study Completion Date : March 1, 2025

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
Group A
Patients are allocated to group A according to preoperative presence of detectable ctDNA.
 Other: Liquid Biopsy
17-20 ml of blood will be collected prior of surgery and within 14 days before start of adjuvant chemotherapy.
Group B
Patients are allocated to group B according to preoperative absence of detectable ctDNA.
 Other: Liquid Biopsy
17-20 ml of blood will be collected prior of surgery and within 14 days before start of adjuvant chemotherapy.


Outcome Measures
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Primary Outcome Measures :
  1. 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)


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Patients with pancreatic mass, suspicious of pancreatic cancer and deemed resectable will be prospectively enrolled in this observational study.
Criteria

Inclusion Criteria:

  1. Adult patients ≥ 18 years of age
  2. Pancreatic mass, suspicious of pancreatic cancer, deemed resectable and resection planned.
  3. Patient deemed medically fit for adjuvant chemotherapy by the investigator
  4. Patient's legal capacity to consent to study participation
  5. Signed and dated informed consent to participate in the study

Exclusion Criteria:

  1. Non-resectable disease as determined by a local tumor board
  2. Metastatic pancreatic disease
  3. Previous neoadjuvant chemotherapy
  4. Previous neoadjuvant radiotherapy
  5. Histology other than PDAC such as acinar, neuroendocrine, mixed histology etc. in the resection specimen
  6. 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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04246203


Contacts
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Contact: Benedikt Westphalen, MD 0049894400 ext 75250 cwestpha@med.lmu.de
Contact: Bernhard W. Renz, MD 0049894400 ext 0 Bernhard.Renz@med.uni-muenchen.de

Locations
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Germany
Ludwig Maximilians University Munich Recruiting
Munich, Bavaria, Germany, 80799
Contact: Benedikt Westphalen, MD    +49894400 ext 75250    cwestpha@med.lmu.de   
Contact: Laura E. Fischer, MD    +49894400 ext 73126    Laura.Fischer@med.uni-muenchen.de   
Charité - Universitätsmedizin Berlin Not yet recruiting
Berlin, Germany
Contact: Uwe Pelzer, MD         
Uniklinik Köln Not yet recruiting
Cologne, Germany
Contact: Dirk Waldschmidt, MD         
Universitätsklinikum Hamburg-Eppendorf Not yet recruiting
Hamburg, Germany
Contact: Marianne Sinn, MD         
Technische Universität München Not yet recruiting
Munich, Germany, 80333
Contact: Michael Quante, MD         
Universitätsklinikum Ulm Not yet recruiting
Ulm, Germany
Contact: Thomas Seufferlein, MD         
Sponsors and Collaborators
Ludwig-Maximilians - University of Munich
Hoffmann-La Roche
Investigators
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Principal Investigator: Benedikt Westphalen LMU Munich
More Information
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Responsible Party: Benedikt Westphalen, Principal Investigator, Ludwig-Maximilians - University of Munich
ClinicalTrials.gov Identifier: NCT04246203    
Other Study ID Numbers: ML40429
First Posted: January 29, 2020    Key Record Dates
Last Update Posted: April 6, 2022
Last Verified: April 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
 Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases