Feasibility Study to Investigate Rectal Mucus in Aero-Digestive Tract Cancer. (ORI-EGI-03)
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| ClinicalTrials.gov Identifier: NCT05102110 |
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Recruitment Status :
Recruiting
First Posted : November 1, 2021
Last Update Posted : January 19, 2024
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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 Upper GI and Lung Pathology as well as contributing to a genomic library collating information about rectal mucus.
| Condition or disease | Intervention/treatment |
|---|---|
| Non Small Cell Lung Cancer Gastric Adenocarcinoma Pancreatic Cancer Gall Bladder Cancer Bladder Cancer | Diagnostic Test: Oricol Test |
The embryological development of the aero-digestive tract (ADT) is from a single primitive layer, the endoderm. Differentiation of this layer leads to epithelial and mucosal histopathological similarities through a continuous connected lumen extending from the upper third of the oesophagus to the anorectal junction and including the organs of the gastrointestinal tract (liver, pancreas, gallbladder) and the respiratory tract (trachea, bronchi and lung).
Cancers of the aero-digestive tract include; non-small cell lung (NSCLC), distal oesophageal, gastric, pancreatic, biliary, small bowel and colorectal cancer. The predominant type of cancer is an adenocarcinoma arising in the glandular cells lining the viscera. These cells have the capacity to secrete mucus and form the inner lining of the lumen All of these cancers directly or indirectly sheds cells into the gastrointestinal tract. The gastrointestinal epithelium regenerates every 5-7 days, the discarded cellular material migrates distally and is excreted as part of faeces. The majority of lung secretions are swallowed creating an interaction with the intestine which, to date, has primarily been studied from the microbiota perspective.
The Covid-19 pandemic has highlighted the strain on traditional diagnostic pathways, with a drop by 90% of the normal endoscopy workload in the first wave of the pandemic emphasising the need for practical investigations that can be used as a triage tool in primary care to discriminate individuals that do not require more invasive diagnostic tests. Rectal mucus sampling is potentially an appealing screening tool; quick, minimally invasive, cost effective, can be serially repeated for potential prognostic value, requires minimal equipment or training, and produces robust DNA material for extraction.
Recent research has demonstrated that stable, good quantity and quality cfDNA from colorectal cancer can be detected by rectal mucus sampling and clinical trials of the technique in symptomatic participants are underway looking at the use of rectal mucus for detection of colonic cancers (ClinicalTrials.gov, NCT identifier: NCT04659590). This unpublished, research has created a genomic profile of colorectal cancer in the rectal mucus using Next Generation Sequencing (NGS) detection of genetic mutations and alterations in methylation, which correlates with the documented genetic mutations associated with colorectal cancer tumour biopsies. Due to the embryological similarities KRAS and p53 are also found in association with other cancers of the GI tract. Discovered in 1983, methylation is a growing field in epigenetics, it is faster and more cost- effective than genetic mutation detection and promises increased sensitivity and specificity. The literature suggests a strong link between methylation changes and tumuorigenesis in cancers of the aero-digestive tract, which solely, or in conjunction with cf-DNA mutation detection, could play a significant role in early diagnosis.
This research aims to provide a novel insight into rectal mucus. The literature unanimously agrees that further research and standardisation of biomarkers and sampling is required. With novel genomic and epigenetic understanding of diagnostic and therapeutic targets a future of personalised oncological care is anticipated.
| Study Type : | Observational |
| Estimated Enrollment : | 300 participants |
| Observational Model: | Case-Control |
| Time Perspective: | Prospective |
| Official Title: | Feasibility Study to Investigate the Genomic and Epigenetic Changes in Rectal Mucus in Non-Colorectal Cancers of the Aero-Digestive Tract (ORI-EGI-03). |
| Actual Study Start Date : | December 1, 2021 |
| Estimated Primary Completion Date : | June 30, 2024 |
| Estimated Study Completion Date : | December 1, 2024 |
| Group/Cohort | Intervention/treatment |
|---|---|
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Non-small cell lung cancer
A cohort of patients with known NSCLC who are assessed.
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Diagnostic Test: Oricol Test
Assessment of rectal mucus for material from aero-digestive cancers. |
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Gastric cancer patient
A cohort of patients with known gastric adenocarcinoma who are assessed.
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Diagnostic Test: Oricol Test
Assessment of rectal mucus for material from aero-digestive cancers. |
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Pancreatic cancer
A cohort of patients with known pancreatic adenocarcinoma who are assessed.
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Diagnostic Test: Oricol Test
Assessment of rectal mucus for material from aero-digestive cancers. |
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Urothelial cancers
A cohort of patients with known uroepithelial cancers who are assessed.
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Diagnostic Test: Oricol Test
Assessment of rectal mucus for material from aero-digestive cancers. |
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Biliary tract cancers
A cohort of patients with known biliary tract cancers who are assessed.
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Diagnostic Test: Oricol Test
Assessment of rectal mucus for material from aero-digestive cancers. |
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Colorectal cacncers
A cohort of patients with known colorectal cancers have been added to the study following methodology change in analysis techniques.
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- Correlation of SNP allele frequency in genes associated with known aero-digestive cancers in paired samples of tumour type and rectal mucus. [ Time Frame: 1 year ]Genomic analysis
Biospecimen Retention: Samples With DNA
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| Ages Eligible for Study: | 18 Years to 99 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
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.
Inclusion Criteria:
Aged 18 years or over Be able to give voluntary, written informed consent to participate in the study
Exclusion Criteria:
Participants with symptoms that would make proctoscopic examination inappropriate, including acute anal fissure, symptomatic thrombosed haemorrhoids or obstructing anorectal lesions as determined by rectal examination Participants with a previous history of cancer Participants who have received previously radiotherapy, chemotherapy or immunotherapy for a malignancy.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05102110
| Contact: Hugo Lywood | 01223 750490 | Hugo.lywood@originsciences.com |
| United Kingdom | |
| Royal Devon & Exeter NHS Foundation Trust | Recruiting |
| Exeter, United Kingdom, EX2 4UG | |
| Contact: Ian Daniels +447920517187 Ian.Daniels@originsciences.com | |
| Study Director: | Mr F McDermott, FRCS | Chief Investigator |
| Responsible Party: | Origin Sciences |
| ClinicalTrials.gov Identifier: | NCT05102110 |
| Other Study ID Numbers: |
ORICOL-EGI-03 |
| First Posted: | November 1, 2021 Key Record Dates |
| Last Update Posted: | January 19, 2024 |
| Last Verified: | January 2024 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Undecided |
| Plan Description: | Dependent upon initial sampling data. |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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Urinary Bladder Neoplasms Gallbladder Neoplasms Neoplasms by Site Neoplasms Digestive System Neoplasms Digestive System Diseases Urologic Neoplasms Urogenital Neoplasms Female Urogenital Diseases |
Female Urogenital Diseases and Pregnancy Complications Urogenital Diseases Urinary Bladder Diseases Urologic Diseases Male Urogenital Diseases Biliary Tract Neoplasms Biliary Tract Diseases Gallbladder Diseases |