ClinicalTrials.gg
Not yet recruitingNCT07903571CLARITYUpdated Oct 29, 2026

Cohort Study to eLucidAte Causes, Behaviour and Outcomes of gastRo Intestinal Tract Cancers in the Young

An observational study in Colorectal Cancer, Gastro-oesophageal Adenocarcinoma and Hepato-Biliary Carcinoma in Situ Nos, sponsored by Royal Marsden NHS Foundation Trust. Not yet recruiting. Open to participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2026-10-29.

Sponsored by Royal Marsden NHS Foundation Trust · Observational

Updated Oct 29, 2026Newly registeredGo to Updates ↓
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
200
Ages
18 Years to 50 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 22 studies in Colorectal Neoplasms by Royal Marsden NHS Foundation Trust — 3 open to participants now, 4 under way, none of them phase 3. Colorectal Neoplasms · Royal Marsden NHS Foundation Trust.

Planned enrollment
5th of 12
200 · median 138
Started
2026
the only one that year
Observational
12 of 22
2 open now
Registered
22nd of 22
by date

Among the 22 studies in Colorectal Neoplasms by Royal Marsden NHS Foundation Trust, this one is the 5th largest by planned enrollment of the 12 observational ones that give a count, is the only one that started in 2026, is one of 12 observational ones, and was the 22nd registered.

Colorectal Neoplasms

6,541 studies on the registry are indexed under Colorectal Neoplasms; 1,667 are open to participants now.

Browse Colorectal Neoplasms studies →

Open to participants now

3 of the 22 studies in Colorectal Neoplasms by Royal Marsden NHS Foundation Trust are open now, in 1 country. Recruiting first, the newest first:

By country, each count listing its studies:

All 3 open studies →

Who these studies take

Of the 1,185 Colorectal Neoplasms studies recruiting now, 769 (65%) set no upper age limit and 265 (22%) stop at 75 or younger; 48 take children under 18; 123 take healthy volunteers.

This study: 18 Years to 50 Years · all sexes · no healthy volunteers.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 22 studies in Colorectal Neoplasms by Royal Marsden NHS Foundation Trust, or all of them as a file.
02

Study summary

This study aims to better understand how gastrointestinal (digestive system) cancers develop and how they respond to treatment in young adults, in order to improve ways to prevent, diagnose, and manage these cancers in this age group.

Read the detailed description

This prospective study is designed to establish a database of young adult patients diagnosed with gastro-intestinal malignancies, with availability of matched clinical data and biological samples including but not limited to tumour tissue. This will serve as a valuable platform to sub studies and collaboration with national and international groups, to better understand the pathogenesis of cancers in this unique cohort and to better tailor treatment to maximise efficacy and minimise toxicity. The analysis plan will develop as the study progresses. At the outset, three areas of interest for investigation are molecular profiling of the tumour and it's microenvironment, the intestinal microbiome and collaboration with groups developing patient derived organoids and metabolomics. It may also provide a platform for future longitudinal research to identify long term health trends.

03

Conditions studied

  • Colorectal Cancer
  • Gastro-oesophageal Adenocarcinoma
  • Hepato-Biliary Carcinoma in Situ Nos

Keywords

  • prospective
  • translational
  • tissue collection
  • gastro-intestinal cancers
  • young adults
04

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients must be receiving treatment at The Royal Marsden NHS Foundation Trust.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. -Cohort A: Colorectal Cancer including at least 20 patients with appendiceal cancer.

    • Cohort B: Gastro-oesophageal cancer
    • Cohort C: Hepato-biliary cancer
  2. Patient is 18-50 years of age 3 Patient can understand the patient information sheet and is able to provide written .

4. Patient being treated at the Royal Marsden Hospital.

Exclusion criteria

Exclusion Criteria:

  1. Patients who have received prior treatment for their gastrointestinal (includes any systemic anti-cancer therapy, radiotherapy and / or surgical resection.
  2. Patients with a cancer of pancreatic origin (existing institutional biobank), or hepatocellular carcinoma (HCC)
  3. Patients with a history another of malignancy with within 2 years, excluding resected non melanomatous skin cancers.

    -

Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
200 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • Cohort A

    Patients aged under 50 with colorectal cancer (including at least 20 patients with appendiceal cancer)

    Biological: Research blood samples

  • Cohort B

    Patients aged 18-50 with gastro-oesophageal cancer

    Biological: Research blood samples

  • Cohort C

    Patients aged 18-50 with Hepato-biliary cancer.

    Biological: Research blood samples

Interventions

  • BiologicalResearch blood samples

    Sample taken at baseline, 8-12 weeks post first treatment commencement and at first disease progression or relapse.

06

What researchers measure

Primary outcomes

  1. Establishment of a prospective early-onset gastrointestinal cancer cohort and biorepositor

    Number of participants recruited to the cohort with linked biospecimen collection, clinical data capture, and longitudinal follow-up completed according to protocol.

    Time frame: 5 years

Secondary outcomes

  1. Lifestyle, dietary, environmental, and early-life exposures

    Characterisation of lifestyle, dietary, environmental, and early-life factors and their association with cancer subtype, molecular characteristics, disease stage, and clinical outcomes.

    Time frame: Baseline and up to 5 years follow-up

  2. Gut microbiome characteristics

    Association between gut microbiome composition and tumour characteristics, treatment response, disease progression, and survival outcomes.

    Time frame: Baseline and up to 5 years follow-up

  3. Circulating biomarkers and translational research markers

    Changes in patient-reported quality of life following diagnosis and treatment of early-onset gastrointestinal cancer, as measured using validated questionnaires.

    Time frame: Baseline and up to 5 years follow-up

Other outcomes

  1. Development of patient-derived in vivo models

    Proportion of collected tumour samples successfully used to establish and characterise patient-derived animal models.

    Time frame: up to 5 years.

  2. Development of patient-derived organoid models

    Proportion of collected tumour samples successfully used to establish and characterise patient-derived organoid models for translational research studies.

    Time frame: up to 5 years

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: Undecided — Undecided at present

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Nov 2026; primary completion for Nov 2031, 60 months later.

Of 528 non-industry observational studies under Colorectal Neoplasms, half reached primary completion within 56 months of starting (the median), counting those still running; a quarter within 27 and three quarters within 132. This study's planned 60 months is close to that.

Counting every sponsor, half of 645 studies reached it within 51 months; a quarter within 27 and three quarters within 104.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 2, 2026
First posted
Oct 29, 2026
StartEst.
Nov 1, 2026
Primary completionEst.
Nov 1, 2031
CompletionEst.
Nov 1, 2032
Last update
Oct 29, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Registered
First appeared on the registry. No changes since
Oct 29, 2026
Show all 1 update
  1. Oct 29, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07903571
Responsible party
Sponsor
First posted
Oct 29, 2026
Start date
Nov 1, 2026 (estimated)
Primary completion
Nov 1, 2031 (estimated)
Completion
Nov 1, 2032 (estimated)
Last update
Oct 29, 2026

Study contacts

Claire M Saffery
Contact
claire.saffery@rmh.nhs.uk
+44208 915 4480
GI Trials GI Trials
Contact
gi.trials@rmh.nhs.uk
Professor Naureen Starling, FRCP, MD. MRCP, MBBS, BSc Hons
principal investigator · Royal Marsden NHS Foundation Trust

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

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