Adenocarcinoma of the Gastroesophageal JunctionNCT01851928
Validation of a Nutrition Screening Tool
An observational study of Adenocarcinoma of the Gastroesophageal Junction and Cervical Cancer, run by Royal Marsden NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
The objective of this study is to evaluate the sensitivity and specificity of two nutrition screening tools to identify inpatients with malnutrition or at risk of malnutrition. The two tools are the Royal Marsden Abridged Adult Nutrition Screening Tool (AANST) and the Malnutrition Screening Tool (MST)[10] The tools… Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Adenocarcinoma of the Gastroesophageal Junction, Cervical Cancer, Endometrial Cancer
- How many people
- 128 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jul 2011to Mar 2013
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Patients will be approached for consideration and recruitment to the study in a stratified manner in order to proportionately represent the diagnostic groups admitted to The Royal Marsden NHS Foundation Trust as inpatients. Patients will be approached sequentially from the list until the required number of patients are recruited for that particular diagnoses. Recruitment for particular diagnostic groups may take place over a number of days until the required number of patients is recruited. The same procedure will be repeated, with a newly generated list, for all selected diagnostic groups in a random order. This methodology will aim to capture patients who have been newly diagnosed, patients with established disease, patients newly admitted and those who have been inpatients for anumber of days or weeks.
Who may be able to join
- All adult inpatients, over the age of 18, admitted to RMH for whom a measured weight and height can be obtained
Who cannot join
- Patients for whom it is not possible to obtain a measured height and weight
- People with a definitive diagnosis of dementia
- People who lack capacity to understand the purpose of the study and to consent
- Patients who are unable to understand and speak English
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Royal Marsden Hospital NHS Foundation Trust
London, London .., SW3 6JJ
About this study
Official title: The Validation of Two Inpatient Adult Nutrition Screening Tools in Cancer Care - a Prospective Study
The objective of this study is to evaluate the sensitivity and specificity of two nutrition screening tools to identify inpatients with malnutrition or at risk of malnutrition. The two tools are the Royal Marsden Abridged Adult Nutrition Screening Tool (AANST) and the Malnutrition Screening Tool (MST)[10] The tools will be compared with the currently accepted gold standard, Patient Generated Subjective Global Assessment (PG-SGA). Both screening tools are in the form of scored questionnaires and are suitable for electronic input.
The ultimate objective is to select an adult inpatient nutrition screening tool with the highest sensitivity for future use in the oncology inpatient setting in order to allow prompt commencement of an appropriate nutrition care plan.
- Conditions
- Adenocarcinoma of the Gastroesophageal Junction, Cervical Cancer, Endometrial Cancer, Esophageal Cancer, Fallopian Tube Cancer, Gastric Cancer
- Medical subject headings
- Uterine Cervical Neoplasms, Endometrial Neoplasms, Esophageal Neoplasms, Fallopian Tube Neoplasms, Stomach Neoplasms, Ovarian Neoplasms, Sarcoma, Vaginal Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity of Screening Tool
The primary endpoint of the study is the sensitivity of each screening tool as compared to the gold standard of PG-SGA when completed by a trained dietitian.
Measured: 24 hrs
Secondary outcomes (1)
Specificity of the Tool
Secondary endpoints are as follows:
- specificity of the screening tool
- proportion of inpatients with malnutrition on admission
Measured: 24 hrs
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2013 (estimated)
- Study startJul 2011
- Primary completionSep 2012
- Study completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adenocarcinoma of the Gastroesophageal JunctionStudies 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
- 128 participants (actual)
Sponsor and investigators
- Lead sponsor
- Royal Marsden NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Clare Shaw, Phd, Principal investigator, Royal Marsden Hospital NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01851928
- Sponsor's protocol ID
- CCR 3621
- Status last verified
- May 2013
- First submitted
- 20 Apr 2012
- Last updated
- 13 May 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Validation of Two Inpatient Adult Nutrition Screening Tools in Cancer Care - a Prospective Study
- ClinicalTrials.gov ID
- NCT01851928
- Acronym / sponsor ID
- CCR 3621
- Conditions
- Adenocarcinoma of the Gastroesophageal Junction, Cervical Cancer, Endometrial Cancer, Esophageal Cancer, Fallopian Tube Cancer, Gastric Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 128 participants (actual)
- Lead sponsor
- Royal Marsden NHS Foundation TrustUniversity, hospital or other
- Study start
- Jul 2011
- Primary completion
- Sep 2012 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 13 May 2013 (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.
The objective of this study is to evaluate the sensitivity and specificity of two nutrition screening tools to identify inpatients with malnutrition or at risk of malnutrition. The two tools are the Royal Marsden Abridged Adult Nutrition Screening Tool (AANST) and the Malnutrition Screening Tool (MST)[10] The tools will be compared with the currently accepted gold standard, Patient Generated Subjective Global Assessment (PG-SGA). Both screening tools are in the form of scored questionnaires and are suitable for electronic input.
The ultimate objective is to select an adult inpatient nutrition screening tool with the highest sensitivity for future use in the oncology inpatient setting in order to allow prompt commencement of an appropriate nutrition care plan.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Patients will be approached for consideration and recruitment to the study in a stratified manner in order to proportionately represent the diagnostic groups admitted to The Royal Marsden NHS Foundation Trust as inpatients. Patients will be approached sequentially from the list until the required number of patients are recruited for that particular diagnoses. Recruitment for particular diagnostic groups may take place over a number of days until the required number of patients is recruited. The same procedure will be repeated, with a newly generated list, for all selected diagnostic groups in a random order. This methodology will aim to capture patients who have been newly diagnosed, patients with established disease, patients newly admitted and those who have been inpatients for anumber of days or weeks.
Key inclusion criteria (1 listed)
- All adult inpatients, over the age of 18, admitted to RMH for whom a measured weight and height can be obtained
Key exclusion criteria (4 listed)
- Patients for whom it is not possible to obtain a measured height and weight
- People with a definitive diagnosis of dementia
- People who lack capacity to understand the purpose of the study and to consent
- Patients who are unable to understand and speak English
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Sensitivity of Screening Tool
Time frame: 24 hrs
The primary endpoint of the study is the sensitivity of each screening tool as compared to the gold standard of PG-SGA when completed by a trained dietitian.
1 secondary outcome
Specificity of the Tool
Time frame: 24 hrs
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2013.
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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.
Clare Shaw, Phd principal investigator
Royal Marsden Hospital NHS Foundation Trust
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 Adenocarcinoma of the Gastroesophageal Junction and Cervical 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 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: finished, as of the sponsor's last update on 13 May 2013. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Sensitivity of Screening Tool (time frame: 24 hrs). 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 13 May 2013.