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New biomarkers for prediction of response to FOLFIRINOX chemotherapy in pancreatic cancer patients.

New biomarkers for prediction of response to FOLFIRINOX chemotherapy in pancreatic cancer patients. - iKnowIT

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON46821
Enrollment
200
Registered
2018-06-08
Start date
2018-07-13
Completion date
Unknown
Last updated
2024-04-15

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

Conditions

pancreatic cancer pancreatic ductal adenocarcinoma

Interventions

The intervention consists of 2 additional blood draws during a standard visit to the outpatient clinic. During each visit 5 additional tubes of blood (43 ml) will be collected.

Sponsors

Erasmus MC, Universitair Medisch Centrum Rotterdam
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: * Age * 18 years * Diagnosed with (borderline) resectable, locally advanced or metastasized pancreatic cancer * Treatment with FOLFIRINOX chemotherapy, including neoadjuvant and adjuvant therapy * Written informed consent

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

Secondary

MeasureTime frame
* Response rate * Number of adverse events * Resection rate * Progression free survival * Overall survival.

Primary

MeasureTime frame
Differences in expression between responders and non-responders and between patients who experience severe toxicity and those who do not, based on: * SNPs * ctDNA mutations * miRNA patterns * Microbiome patterns * Immune profiles

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)