Dataset Information

Circulating Tumour DNA as a Marker of Complete Pathological Response and Long Term Outcome for Locally Advanced Rectal Cancer Treated with Pre-operative Chemoradiotherapy

ABSTRACT: Interventions: This is an exploratory prospective study involving the collection of blood samples for the purposes of measuring circulating tumour DNA from patients with locally advanced rectal cancer planned for pre-operative CRT followed by definitive surgery and post operative chemotherapy. Patients will be treated and followed according to standard practice.The collection of serial blood samples at specifed timepoints. The timepoints are as follows Timepoint 1 baseline (prior to chemo radiation), timepoint 2 4 – 6 weeks post chemo-radiation and the final timepoint (timepoint 3)being 4 – 10 weeks post surgery. For this study there are three timepoints for blood collection and at each time point 60mls of blood will be collected. Each patient’s treating surgeon will assess and document the clinical response to CRT prior to surgery. Resected tumour samples will be made available after surgery for mutation analysis. If there is no or minimal residual disease in the resected specimen, then the preoperative diagnostic biopsy will be used. Histology slides will be made available for central assessment of pathological response to chemoradiation. Follow-up will be as per standard practice, including 3-monthly CEA and annual CT chest/abdomen/pelvis for at least 2 years. Primary outcome(s): To demonstrate that the eradication of circulating tumour DNA (ctDNA) in peripheral blood following completion of pre-operative chemoradiotherapy (CRT) is a sensitive and specific predictor of complete pathological response (pCR) in locally advanced rectal cancer.[Analysis of blood/plasma and tissue samples collected throughout the study. Timepoint 1 baseline (prior to chemo radiation), timepoint 2 is 4 - 6 weeks post chemo-radiation and the final timepoint (timepoint 3) being 4 - 10 weeks post surgery. For this study there are three timepoints for blood collection and at each time point 60mls of blood will be collected.]

DISEASE(S): Nil,Patients With Locally Advanced Rectal Cancer Planned For Pre-operative Crt Followed By Definitive Surgery And Post Operative Chemotherapy,Cancer-bowel-back Passage (rectum) Or Large Bowel (colon)

PROVIDER: 2458039 | ecrin-mdr-crc |

REPOSITORIES: ECRIN MDR

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Dataset Information

Circulating Tumour DNA as a Marker of Complete Pathological Response and Long Term Outcome for Locally Advanced Rectal Cancer Treated with Pre-operative Chemoradiotherapy

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