Prognostic Role of Circulating Tumor DNA in Resectable Pancreatic Cancer

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.

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Key information

Conditions

Pancreas Cancer Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Neoplasms Neoplasms by Site Pancreatic Diseases Pancreatic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Ludwig Maximilians University Munich, Munich, Bavaria, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Liquid Biopsy

Other

17-20 ml of blood will be collected prior of surgery and within 14 days before start of adjuvant chemotherapy.

Primary outcomes

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)

Sponsors and collaborators

Lead sponsor

Ludwig-Maximilians - University of Munich

Other

Collaborators

Hoffmann-La Roche

Registry information

Acronym: PROJECTION

Important dates

Study start: 2021
Primary completion: 2025
Study completion: 2026
First posted: Jan 29, 2020
Registry last updated: Mar 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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