Oesophageal CancerNCT05233007
Upper GI Serial Tumour Biopsies
An observational study of Oesophageal Cancer and Gastric Cancer, run by The Christie NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
This is a prospective translational research study in which tumour samples, blood samples and other biospecimens will be requested from patients with locally advanced or metastatic malignant oesophageal and gastric carcinoma. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Oesophageal Cancer, Gastric Cancer
- What is being tested?
- Minor endoscopic biopsy
- Type of treatment
- Surgery or procedure
- How many people
- 300 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 25 Jan 2022to Oct 2028
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Upper GI cancer patients, as determined by practicing oncologist
Who may be able to join
- Age of 18 years or more.
- Patients must have given written informed consent.
- Evidence of locally advanced or metastatic oesophageal and gastric carcinoma, i.e. stage III or IV disease.
- Accessible tumour that can be safely biopsied using radiological or surgical techniques (if consenting to part A).
- Full blood count and coagulation tests within acceptable parameters (if consenting to part A).
Who cannot join
- Inability to provide informed consent.
- History of significant bleeding disorder (patients on anticoagulation are eligible if the anticoagulation can be safely managed to allow fresh tumour biopsies and blood sampling).
- History of HIV, Hepatitis B/C or other transmissible human disease.
- Any conditions where research biopsies or blood sampling may increase risk of complications for the patient and/or investigator, including high risk groups such as intravenous drug users.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
The Christie Hospital NHS Foundation Trust
Manchester, Greater Manchester, M20 4BX
About this study
Official title: Molecular Characterisation of Serial Tumour Samples and Their Correlation With Circulating Biomarkers and Other Biospecimens Taken During the Clinical Course of Patients Receiving Treatment for Upper Gastrointestinal Carcinomas.
This is a prospective translational research study in which tumour samples, blood samples and other biospecimens will be requested from patients with locally advanced or metastatic malignant oesophageal and gastric carcinoma. There are two parts to the study:
- Part A - evaluation of serial tumour biopsies
- Part B - evaluation of circulating biomarkers and other biospecimens
Read the detailed description
This is a prospective, non-randomised, non-interventional, translational research study in which patients with locally advanced or metastatic oesophageal and gastric carcinoma will be asked to donate tissue, blood and other available biospecimens for translational and biomarker research. This is an exploratory biomarker study to generate preliminary data for future research projects incorporating identified aberrations.
The overall aims of the study are to employ serial tumour biopsies, blood borne biomarkers and other biospecimens to investigate mechanisms of resistance to systemic therapy and develop predictive biomarkers of this resistance in patients with locally advanced and metastatic malignant oesophageal and gastric carcinoma. Blood biomarkers will include enumeration and characterisation of circulating blood cell subtypes, as well as the evaluation of circulating cell-free proteins and nucleic acids. Other biospecimens include urine, stool and hair follicle samples that the patient is willing to donate for research purposes, and ascitic, pleural, pericardial or cerebral spinal fluid, available to collect as part of clinically indicated procedures (standard care) and surplus to routine clinical requirements. These other biospecimens would be stored at the Biobank.
- Conditions
- Oesophageal Cancer, Gastric Cancer
- Being tested
- Minor endoscopic biopsy
- Medical subject headings
- Esophageal Neoplasms, Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Minor endoscopic biopsyProcedure or surgery
As per standard of care
| Study group | Role | What they receive |
|---|---|---|
| All participants | All eligible, consented participants, will be asked to give blood, tissue, and other biospecimens for research purposes Receives: Procedure: Minor endoscopic biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine levels of circulating biomarkers in upper GI cancer patients
To determine detectable levels of circulating biomarkers in patients with locally advanced and metastatic oesophageal and gastric carcinoma.
Measured: 20 years
Correlating levels of biomarkers
To correlate circulating biomarker characteristics with serial tumour biopsies.
Measured: 20 years
Predicting treatment resistance to anti-cancer therapy
To correlate sequencing/profiling data with clinical outcome data, including prognosis and response to systemic therapy.
Measured: 20 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2022
- Study start25 Jan 2022
- Primary completionOct 2028 (estimated)
- Study completionOct 2028 (estimated)
Why it stopped: To explore alternative funding streams
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oesophageal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Christie NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05233007
- Sponsor's protocol ID
- CFTSp209
- Other IDs
- 21/WM/0264, 304901
- Status last verified
- Feb 2024
- First submitted
- 31 Jan 2022
- Last updated
- 8 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Molecular Characterisation of Serial Tumour Samples and Their Correlation With Circulating Biomarkers and Other Biospecimens Taken During the Clinical Course of Patients Receiving Treatment for Upper Gastrointestinal Carcinomas.
- ClinicalTrials.gov ID
- NCT05233007
- Acronym / sponsor ID
- CFTSp209
- Conditions
- Oesophageal Cancer, Gastric Cancer
- Study type
- Observational
- Recruitment status
- SuspendedReason stopped: To explore alternative funding streams
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- The Christie NHS Foundation TrustUniversity, hospital or other
- Study start
- 25 Jan 2022 (actual)
- Primary completion
- Oct 2028 (estimated)
- Study completion
- Oct 2028 (estimated)
- First posted
- 10 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a prospective translational research study in which tumour samples, blood samples and other biospecimens will be requested from patients with locally advanced or metastatic malignant oesophageal and gastric carcinoma. There are two parts to the study:
- Part A - evaluation of serial tumour biopsies
- Part B - evaluation of circulating biomarkers and other biospecimens
Detailed description
This is a prospective, non-randomised, non-interventional, translational research study in which patients with locally advanced or metastatic oesophageal and gastric carcinoma will be asked to donate tissue, blood and other available biospecimens for translational and biomarker research. This is an exploratory biomarker study to generate preliminary data for future research projects incorporating identified aberrations.
The overall aims of the study are to employ serial tumour biopsies, blood borne biomarkers and other biospecimens to investigate mechanisms of resistance to systemic therapy and develop predictive biomarkers of this resistance in patients with locally advanced and metastatic malignant oesophageal and gastric carcinoma. Blood biomarkers will include enumeration and characterisation of circulating blood cell subtypes, as well as the evaluation of circulating cell-free proteins and nucleic acids. Other biospecimens include urine, stool and hair follicle samples that the patient is willing to donate for research purposes, and ascitic, pleural, pericardial or cerebral spinal fluid, available to collect as part of clinically indicated procedures (standard care) and surplus to routine clinical requirements. These other biospecimens would be stored at the Biobank.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All participants | – | Procedure: Minor endoscopic biopsyAll eligible, consented participants, will be asked to give blood, tissue, and other biospecimens for research purposes |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Upper GI cancer patients, as determined by practicing oncologist
Key inclusion criteria (5 listed)
- Age of 18 years or more.
- Patients must have given written informed consent.
- Evidence of locally advanced or metastatic oesophageal and gastric carcinoma, i.e. stage III or IV disease.
- Accessible tumour that can be safely biopsied using radiological or surgical techniques (if consenting to part A).
- Full blood count and coagulation tests within acceptable parameters (if consenting to part A).
Key exclusion criteria (4 listed)
- Inability to provide informed consent.
- History of significant bleeding disorder (patients on anticoagulation are eligible if the anticoagulation can be safely managed to allow fresh tumour biopsies and blood sampling).
- History of HIV, Hepatitis B/C or other transmissible human disease.
- Any conditions where research biopsies or blood sampling may increase risk of complications for the patient and/or investigator, including high risk groups such as intravenous drug users.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Minor endoscopic biopsyAs per standard of care | Procedure or surgery | All participants |
Primary outcome
Determine levels of circulating biomarkers in upper GI cancer patients
Time frame: 20 years
To determine detectable levels of circulating biomarkers in patients with locally advanced and metastatic oesophageal and gastric carcinoma.
Correlating levels of biomarkers
Time frame: 20 years
To correlate circulating biomarker characteristics with serial tumour biopsies.
Predicting treatment resistance to anti-cancer therapy
Time frame: 20 years
To correlate sequencing/profiling data with clinical outcome data, including prognosis and response to systemic therapy.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Oesophageal Cancer and Gastric Cancer, run by The Christie NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 8 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determine levels of circulating biomarkers in upper GI cancer patients (time frame: 20 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2024.