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JOURNAL ONKOLOGIE – STUDIE
PROJECTION

Prognostic Role of Circulating Tumor DNA in Resectable Pancreatic Cancer

Rekrutierend

NCT-Nummer:
NCT04246203

Studienbeginn:
Dezember 2021

Letztes Update:
13.03.2024

Wirkstoff:
-

Indikation (Clinical Trials):
Pancreatic Neoplasms

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
-

Sponsor:
Ludwig-Maximilians - University of Munich

Collaborator:
Hoffmann-La Roche

Studienleiter

Benedikt Westphalen
Principal Investigator
LMU Munich

Kontakt

Studienlocations
(3 von 6)

Ludwig Maximilians University Munich
80799 Munich
(Bayern)
GermanyRekrutierend» Google-Maps
Ansprechpartner:
Benedikt Westphalen, MD
Phone: +49894400
Phone (ext.): 75250
E-Mail: cwestpha@med.lmu.de

Laura E. Fischer, MD
Phone: +49894400
Phone (ext.): 73126
E-Mail: Laura.Fischer@med.uni-muenchen.de» Ansprechpartner anzeigen
Alle anzeigen

Studien-Informationen

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.

Ein-/Ausschlusskriterien

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)

Studien-Rationale

Primary outcome:

1. 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)

Studien-Arme

  • Group A
    Patients are allocated to group A according to preoperative presence of detectable ctDNA.
  • Group B
    Patients are allocated to group B according to preoperative absence of detectable ctDNA.

Geprüfte Regime

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

Quelle: ClinicalTrials.gov


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