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NCT04246203Active, not recruiting

Prognostic Role of Circulating Tumor DNA in Resectable Pancreatic Cancer

Source: ClinicalTrials.gov · Last updated 11 Mar 2025

Brief summary (registry, in English)

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.

Status (registry)
Active, not recruiting
Study type
Observational
Enrollment
200 (estimated)
First submitted
26 Jan 2020
Start date
12 Dec 2021
Primary completion date
1 Dec 2025
Lead sponsor
Ludwig-Maximilians - University of Munich
NCT number
NCT04246203

What you commit to

  • Study type: Observational
  • Planned participants: 200
  • From 12 Dec 2021 to the primary completion date, 1 Dec 2025
  • 6 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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)

Other illness

  • Non-resectable disease as determined by a local tumor board
  • Metastatic pancreatic disease

Who the study is looking for

  • 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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (6)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Charité Universitätsmedizin Berlin
Coordinator of this site? Confirm its status
BerlinGermanyUnknown status
Uniklinik Köln
Coordinator of this site? Confirm its status
CologneGermanyUnknown status
Universitätsklinikum Hamburg-Eppendorf
Coordinator of this site? Confirm its status
HamburgGermanyUnknown status
Ludwig Maximilians University Munich
Coordinator of this site? Confirm its status
MunichGermanyUnknown status
Technische Universität München
Coordinator of this site? Confirm its status
MunichGermanyUnknown status
Universitätsklinikum Ulm
Coordinator of this site? Confirm its status
UlmGermanyUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.