A study to investigate whether a biomarker in the blood can predict cancer recurrence in patients with pancreatic cancer

Not Applicable

• Conditions: Pancreatic adenocarcinoma; Cancer - Pancreatic

• Registration Number: ACTRN12612000763842
• Lead Sponsor: udwig Institute for Cancer Research

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-07-18
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

1. Patients with resectable pancreatic adenocarcinoma who are to have a resection of their tumour.
2. ECOG performance status 0 - 2.
3. Patients willing to provide written informed consent.

Exclusion Criteria

1. History of another primary cancer within the last 5 years, with the exception of non-melanomatous skin cancer and carcinoma in situ of the cervix.
2. Medical or psychiatric condition or occupational responsibilities that may preclude compliance with the protocol.
3. Patients that are not accessible for follow-up.
4. Preoperative chemotherapy or radiotherapy.

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To demonstrate that persistence of tumour derived DNA in peripheral blood following complete resection of the primary tumour is a sensitive and specific marker of subsequent disease recurrence.[At the completion of analysis of blood, plasma and tissue samples.<br><br>Study participants will have 15 mls of blood collected at 2 time points:<br>Time point 1: Pre-surgery<br>Time point 2: 4 - 8 weeks post surgery]

Secondary Outcome Measures

Name	Time	Method
To demonstrate that the disappearance of tumour DNA in peripheral blood is a sensitive and specific marker of benefit from adjuvant chemotherapy.[At the completion of analysis of blood and plasma samples.<br><br>Study participants will have 15 mls of blood collected at 2 time points:<br>Time point 1: Pre-surgery<br>Time point 2: 4 - 8 weeks post surgery];To explore the potential of the appearance or re-appearance of ctDNA of tumour DNA in peripheral blood as a specific and sensitive marker of disease recurrence.[At the completion of analysis of blood and plasma samples.<br><br>Study participants will have 15 mls of blood collected at 2 time points:<br>Time point 1: Pre-surgery<br>Time point 2: 4 - 8 weeks post surgery]