Clinical trialNAUnknown
Precision-Panc Master Protocol: Personalising Treatment for Pancreatic Cancer
Precision-Panc Master Protocol: Personalising Treatment For Pancreatic Cancer
- Outcome
- Outcome unknown
- Phase
- NA
- Status
- Unknown
- Study type
- Interventional
- Start
- 28 November 2017
- Expected end
- 31 December 2025
- Enrollment
- 2,500 participants
- Sites
- 33
- Primary outcomes
- Proving that patients with pancreatic cancer can have their tissue molecularly assessed and be followed up in a clinical trial setting
- Sponsor
- Other
- Results posted
- No
- Last update
- 8 February 2024
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Brief summary public domain (ClinicalTrials.gov)
The Precision-Panc Master Protocol is a "portal" protocol for patients with known or suspected pancreatic cancer to be accrued through multiple centres in the UK, with the option of being subsequently enrolled into PRIMUS (Pancreatic canceR Individualised Multi-arm Umbrella Studies) examining different treatment regimens and/or biomarker development. Eligible patients will undergo tumour biopsy and blood collection prospectively for molecular profiling at a central laboratory and the results may be used to inform enrolment to PRIMUS studies.
Intervention public domain (ClinicalTrials.gov)
Other: Patients with suspected or confirmed pancreatic cancer will be be asked to provide biopsy material for molecular profiling. Patients with suspected or confirmed pancreatic cancer will be be asked to provide biopsy material for molecular profiling. This will enable patient enrolment into a currently available PRIMUS study
Arm public domain (ClinicalTrials.gov)
Biopsy Material Required for Registration (other): The Precision-Panc Master Protocol aims to recruit, consent and screen patients with pancreatic cancer
Primary outcome public domain (ClinicalTrials.gov)
Proving that patients with pancreatic cancer can have their tissue molecularly assessed and be followed up in a clinical trial setting. The number of patients screened and registered to the master protocol will be recorded. The number of patients who we are able to molecular assess will be recorded and all patients will be followed up in the master protocol until death. Time frame: At end of study (5 years).
Secondary outcome public domain (ClinicalTrials.gov)
Overall Survival. Time frame: From date of registration until date of death from any cause, assessed up to 5 years.
Secondary outcome public domain (ClinicalTrials.gov)
Number of participants with biopsy related adverse events as assesed by CTCAE v4.03. Time frame: At time of biopsy, usually within one week of screening.
Eligibility public domain (ClinicalTrials.gov)
Inclusion Criteria: * Adult patients (age \>16 years). * Either: * Presence of a hypodense pancreatic mass highly suspicious of primary pancreatic cancer with or without distant metastasis as assessed by a Pancreatic Multi-Disciplinary Team (MDT). Or o Histologically or cytologically confirmed pancreatic ductal adenocarcinoma and its variants. * Patient is willing and able to undergo additional tumour biopsy (from the primary or a metastatic site) aimed at obtaining sufficient tissue for molecular profiling if this is required. * Patient is deemed suitable to receive chemotherapy and/or radiotherapy, and/or surgery pending stage of disease at presentation. * Patient is deemed potentially eligible for a currently open PRIMUS study * Patient has signed informed consent for screening research tumour biopsy (Consent 1). * Patient has signed informed consent for Precision-Panc Master Protocol molecular profiling (Consent 2).
Enrollment public domain (ClinicalTrials.gov)
Enrollment: 2500 participants (estimated).