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

  • STATUS
    Recruiting
  • End date
    Mar 1, 2025
  • participants needed
    200
  • sponsor
    Ludwig-Maximilians - University of Munich
Updated on 25 April 2022
cancer chemotherapy
pdac
resectable pancreatic cancer
pancreatic neoplasm

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.

Details
Condition Pancreas Cancer
Treatment Liquid Biopsy
Clinical Study IdentifierNCT04246203
SponsorLudwig-Maximilians - University of Munich
Last Modified on25 April 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

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

Exclusion Criteria

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)
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