Local recurrence of malignant tumor of pancreas (disorder)

Clinical Trial: SCALOP-2

Year Started: 2017

T-SCALOP is the translational sample collection associated with the SCALOP-2 trial. The SCALOP2 trial is a randomised phase II/III study with a 2x2 factorial design plus an additional chemotherapy control arm in patients with locally advanced non-metastatic pancreatic cancer. Patients whose disease remains stable after treatment with gemcitabine and abraxane will be randomised to one of five arms, consisting of capecitabine in combination with radiotherapy, with and without inclusion of the Phospho-AKT inhibitor nelfinavir, and a chemotherapy control arm receiving gemcitabine and abraxane alone. The study aims to recruit 262 patients over a period of 48 months from 40 UK centres. T-SCALOP aims to establish a collection of samples focusing on developing blood-borne biomarkers for tumour detection and response prediction. In addition to residual tumour tissue from diagnostic biopsy, research blood will be collected from patients at trial entry, start of chemoradiotherapy, 4-6 weeks after chemoradiotherapy and at progression. The samples will be used to compare tumour DNA with circulating cell-free plasma DNA to determine whether blood borne biomarkers can be used as a surrogate for primary tumour. They will also help determine whether alteration in the levels of specific somatic events correlate with benefit of a given intervention. The collection will also help to evaluate plasma biomarkers related to hypoxia before and during nelfinivir treatment and correlate with clinical outcome. The sample collection has been held in the Wales Cancer Bank since 2022. For sample enquiries, please contact WCB directly.



Access:
Access restricted at present
Type:
Clinical Trial
Status:
Completed
Consent restrictions:
No restrictions


Associated Data Type Procurement Timeframe
Clinical records > 6 months
Followup records > 6 months
Pathology records > 6 months


Male

Adult (> 40 years)

1 - 10 donors

Material Type Extraction Procedure Storage Temperature Preservation Type Macroscopic Assessment % of Sample Set
Serum -60°C to -85°C N/A Not applicable 0 - 10%


Female

Adult (> 40 years)

101 - 500 donors

Material Type Extraction Procedure Storage Temperature Preservation Type Macroscopic Assessment % of Sample Set
Serum -60°C to -85°C N/A Not applicable 51 - 75%