PROJECTION: Prognostic Role of Circulating Tumor DNA in Resectable Pancreatic Cancer

Sponsor
Ludwig-Maximilians - University of Munich (Other)
Overall Status
Recruiting
CT.gov ID
NCT04246203
Collaborator
Hoffmann-La Roche (Industry)
200
Enrollment
6
Locations
38.6
Anticipated Duration (Months)
33.3
Patients Per Site
0.9
Patients Per Site Per Month

Study Details

Study Description

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 DiseaseIntervention/TreatmentPhase
  • Other: Liquid Biopsy

Study Design

Study Type:
Observational
Anticipated 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 :
Dec 12, 2021
Anticipated Primary Completion Date :
Mar 1, 2024
Anticipated Study Completion Date :
Mar 1, 2025

Arms and Interventions

ArmIntervention/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

Primary Outcome Measures

  1. DFS [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

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
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

Locations

SiteCityStateCountryPostal Code
1Ludwig Maximilians University MunichMunichBavariaGermany80799
2Charité - Universitätsmedizin BerlinBerlinGermany
3Uniklinik KölnCologneGermany
4Universitätsklinikum Hamburg-EppendorfHamburgGermany
5Technische Universität MünchenMunichGermany80333
6Universitätsklinikum UlmUlmGermany

Sponsors and Collaborators

  • Ludwig-Maximilians - University of Munich
  • Hoffmann-La Roche

Investigators

  • Principal Investigator: Benedikt Westphalen, LMU Munich

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Benedikt Westphalen, Principal Investigator, Ludwig-Maximilians - University of Munich
ClinicalTrials.gov Identifier:
NCT04246203
Other Study ID Numbers:
  • ML40429
First Posted:
Jan 29, 2020
Last Update Posted:
Apr 6, 2022
Last Verified:
Apr 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 6, 2022