Oesophageal CancerNCT00220077
Determination of the Role of Microarray for Prognosis and Prediction to Chemotherapy Sensitivity in Patients With Operable, Locally Advanced and Metastatic Oesophageal Cancer
A study testing Endoscopy in people with Oesophageal Cancer, run by Royal Marsden NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
Knowledge of the impact of gene expression profiling could allow optimisation of chemotherapy regimens for individual patients. It could ensure that patients do not receive a particular form of chemotherapy if it is unlikely to benefit them, and in these circumstances an alternative form of chemotherapy that may prove… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Oesophageal Cancer
- What is being tested?
- Endoscopy
- Type of treatment
- Surgery or procedure
- How many people
- 400 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jun 2002to not given
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Any patient with histologically proven operable ,locally advanced and metastatic oesophageal or gastric carcinoma.
Who cannot join
- Second malignancy
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Royal Marsden Hospital
Sutton, Surrey, SM2 5PT
Sheela Rao, 0208 642 6011, sheela.rao@rmh.nhs.uk
Naureen Starling, 0208 642 6011, naureen.starling@rmh.nhs
About this study
Knowledge of the impact of gene expression profiling could allow optimisation of chemotherapy regimens for individual patients. It could ensure that patients do not receive a particular form of chemotherapy if it is unlikely to benefit them, and in these circumstances an alternative form of chemotherapy that may prove beneficial could be selected. This information will therefore allow chemotherapy to be tailored to the individual tumour. It may help identify those patients with a poorer prognosis who could be selected for further therapy post surgery or a different treatment strategy at the outset.
- Conditions
- Oesophageal Cancer
- Being tested
- Endoscopy
- Medical subject headings
- Esophageal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EndoscopyProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine whether specific gene expression profiles are associated with response in oesophago-gastric cancer.
Secondary outcomes (1)
Evaluation of the association of gene expression profiling and progression free survival and overall survival in patients with oesophago-gastric cancer.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2005 (estimated)
- Study startJun 2002
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.
- More trials run by Royal Marsden NHS Foundation TrustThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Royal Marsden NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David Cunningham, Principal investigator, Royal Marsden NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00220077
- Sponsor's protocol ID
- 2110
- Status last verified
- Nov 2015
- First submitted
- 19 Sep 2005
- Last updated
- 25 Nov 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determination of the Role of Microarray for Prognosis and Prediction to Chemotherapy Sensitivity in Patients With Operable, Locally Advanced and Metastatic Oesophageal Cancer
- ClinicalTrials.gov ID
- NCT00220077
- Acronym / sponsor ID
- 2110
- Conditions
- Oesophageal Cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Royal Marsden NHS Foundation TrustUniversity, hospital or other
- Study start
- Jun 2002
- First posted
- 22 Sep 2005 (estimated)
- 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.
Knowledge of the impact of gene expression profiling could allow optimisation of chemotherapy regimens for individual patients. It could ensure that patients do not receive a particular form of chemotherapy if it is unlikely to benefit them, and in these circumstances an alternative form of chemotherapy that may prove beneficial could be selected. This information will therefore allow chemotherapy to be tailored to the individual tumour. It may help identify those patients with a poorer prognosis who could be selected for further therapy post surgery or a different treatment strategy at the outset.
Study design
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Any patient with histologically proven operable ,locally advanced and metastatic oesophageal or gastric carcinoma.
Key exclusion criteria (1 listed)
- Second malignancy
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 |
|---|---|---|
| Endoscopy | Procedure or surgery | – |
Primary outcome
To determine whether specific gene expression profiles are associated with response in oesophago-gastric cancer.
1 secondary outcome
Evaluation of the association of gene expression profiling and progression free survival and overall survival in patients with oesophago-gastric cancer.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2015.
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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.
David Cunningham principal investigator
Royal Marsden NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endoscopy in people with Oesophageal Cancer, run by Royal Marsden 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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 25 Nov 2015. 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?
Contact Sheela Rao (0208 642 6011, sheela.rao@rmh.nhs.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To determine whether specific gene expression profiles are associated with response in oesophago-gastric cancer.. 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 25 Nov 2015.