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Validatie van predictieve biomarkers voor FOLFIRINOX respons in patiënten met pancreascarcinoom

Pancreatic cancer: validation of circulating predictive biomarkers

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON21925
Enrollment
240
Registered
2021-07-07
Start date
2021-04-09
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pancreatic cancer

Interventions

None listed

Sponsors

Erasmus University Medical Center, department of Surgery
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: • Age = 18 years. • Diagnosed with (borderline) resectable, locally advanced or metastatic PDAC. • Treatment with FOLFIRINOX chemotherapy, including neoadjuvant therapy in the investigational group ór treatment with gemcitabine (with nab-paclitaxel) in the control group. • Written informed consent (either for PANCAKE in case of locally advanced PDAC and metastasized PDAC or for the PREOPANC-3 trial in case of (borderline) resectable PDAC).

Exclusion criteria

Exclusion criteria: • Combined treatment with other chemotherapeutics then FOLFIRINOX. • Previous treatment with FOLFIRINOX chemotherapy. • Pregnancy. • Serious concomitant systemic disorders that would compromise the safety of the patient or his/her ability to complete the study, at the discretion of the investigator.

Design outcomes

Primary

MeasureTime frame
Differences in circulating tumor DNA, microRNAs, SNPs, and cytokines between patients with disease control and patients with progressive disease during FOLFIRINOX treatment and sensitivity and specificity of these biomarkers.

Contacts

Public ContactFleur van der Sijde

Erasmus University Medical Center

f.vandersijde@erasmusmc.nl0642101567

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)