Feasibility Study to Investigate Rectal Mucus in Aero-Digestive Tract Cancer.
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-99
SponsorOrigin Sciences
About this trial
The aim of the study is to assess the feasibility of genomic and epigenetic analysis of rectal mucus to detect non-colorectal cancers of the aero- digestive tract using samples collected by the OriCol™ Sampling Device.
The primary objective of the study is to assess whether significant changes in DNA mutation and methylation associated with Non-colorectal cancers of the Aero-digestive Tract (NCRCADT) can be detected in rectal mucus as shed cells and cell-free DNA (cfDNA) pass through the gut and theoretically can be collected from rectal mucus.
Secondary objectives will assess the participant acceptability of the OriCol™ Sampling Device for Pancreatic Ductal Adenocarcinoma, Non-Small Cell Cancer of the Lung, Colorectal Cancer and Urological Cancer controls as well as contributing to a genomic library collating information about rectal mucus.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
None
Trial population
Participants with confirmed Non-small Cell Lung Cancer (NSCLC), Oesophageal, Gastric and Duodenal Cancer, Pancreatic Cancer, Biliary Tract Cancer (BTC) who have received a diagnosis but not commenced treatment at the time of participation. Control population will be participants with confirmed Urothelial Cancers who have received a diagnosis but not commenced treatment at the time of participation and participants with no known malignant pathology who have undergone a negative colonoscopy.
Trial design
Design model
Case-control
Time perspective
Prospective
Treatments tested in this trial
Oricol Test
Diagnostic testAssessment of rectal mucus for material from aero-digestive cancers.
Treatment groups
450 Participants
are divided into 4 treatment groupsGroup A: Non-small cell lung cancer1 intervention
Group B: Pancreatic cancer1 intervention
Group C: Urothelial cancers1 intervention
Group D: Colorectal cacncers0 interventions
Trial outcomes
Primary outcomes
1
Correlation of SNP allele frequency in genes associated with known aero-digestive cancers in paired samples of tumour type and rectal mucus.
Genomic analysis
Time frame
1 yearSponsors and contacts
Click on the lead sponsor to view all of their trials.
Origin Sciences
Lead sponsor
Royal Devon and Exeter NHS Foundation Trust
Collaborator
Norfolk and Norwich University Hospitals NHS Foundation Trust
Collaborator
The Leeds Teaching Hospitals NHS Trust
Collaborator
Source ClinicalTrials.gov