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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 : Not yet recruiting
First Posted : January 29, 2020
Last Update Posted : September 2, 2020
Sponsor:
Collaborator:
Hoffmann-La Roche
Information provided by (Responsible Party):
Benedikt Westphalen, Ludwig-Maximilians - University of Munich

Tracking Information
First Submitted Date January 26, 2020
First Posted Date January 29, 2020
Last Update Posted Date September 2, 2020
Estimated Study Start Date January 1, 2021
Estimated Primary Completion Date March 1, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: January 26, 2020)
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)
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Prognostic Role of Circulating Tumor DNA in Resectable Pancreatic Cancer
Official Title Prognostic Role of Circulating Tumor DNA in Resectable Pancreatic Cancer
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.

Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition Pancreas Cancer
Intervention Other: Liquid Biopsy
17-20 ml of blood will be collected prior of surgery and within 14 days before start of adjuvant chemotherapy.
Study Groups/Cohorts
  • Group A
    Patients are allocated to group A according to preoperative presence of detectable ctDNA.
    Intervention: Other: Liquid Biopsy
  • Group B
    Patients are allocated to group B according to preoperative absence of detectable ctDNA.
    Intervention: Other: Liquid Biopsy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Not yet recruiting
Estimated Enrollment
 (submitted: January 26, 2020)
200
Original Estimated Enrollment Same as current
Estimated Study Completion Date March 1, 2025
Estimated Primary Completion Date March 1, 2022   (Final data collection date for primary outcome measure)
Eligibility 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)
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Not Provided
Contacts
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
Listed Location Countries Germany
Removed Location Countries  
 
Administrative Information
NCT Number NCT04246203
Other Study ID Numbers ML40429
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party Benedikt Westphalen, Ludwig-Maximilians - University of Munich
Study Sponsor Ludwig-Maximilians - University of Munich
Collaborators Hoffmann-La Roche
Investigators
Principal Investigator: Benedikt Westphalen LMU Munich
PRS Account Ludwig-Maximilians - University of Munich
Verification Date September 2020