Clinical trial NCT04246203: Prognostic Role of Circulating Tumor DNA in Resectable Pancreatic Cancer
Official title: Prognostic Role of Circulating Tumor DNA in Resectable Pancreatic Cancer
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Pancreas Cancer
Lead sponsor: Ludwig-Maximilians - University of Munich
Sponsor class: OTHER
Collaborators: name: Hoffmann-La Roche
First posted: 2020-01-29
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


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)

Primary outcomes:
measure: DFS
timeFrame: Follow up will be 36 months after surgery.
Secondary outcomes:
Other outcomes:
Locations:
city: Munich
country: Germany
facility: Ludwig Maximilians University Munich
state: Bavaria
city: Berlin
country: Germany
facility: Charité - Universitätsmedizin Berlin
city: Cologne
country: Germany
facility: Uniklinik Köln
city: Hamburg
country: Germany
facility: Universitätsklinikum Hamburg-Eppendorf
city: Munich
country: Germany
facility: Technische Universität München
city: Ulm
country: Germany
facility: Universitätsklinikum Ulm
Study officials:
affiliation: LMU Munich
name: Benedikt Westphalen
role: PRINCIPAL_INVESTIGATOR
References: