Esophageal CancerINSPECTNCT06314516
Influence of Nutrition and Sarcopenia on Esophageal Cancer Outcomes
An observational study of Esophageal Cancer and Sarcopenia, run by Benaroya Research Institute at 1 site in United States.
Trial summary
Prospective multicenter longitudinal (observational) study recruiting from tertiary centers for the surgical management of esophageal cancer; Virginia Mason Medical Center (Seattle, USA) and St Mary's Hospital (Imperial College, London, UK). This is intended to be a pilot study. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Esophageal Cancer, Sarcopenia
- How many people
- 1,717 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Dec 2017to 28 Feb 2024
- 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: International cohort of patients presenting with regional {Stage 2 and 3} esophageal cancer who are considered appropriate candidates for surgical therapy.
Who may be able to join
- Patients with the following characteristics will be eligible for inclusion in this study:
- Age 18-90 years
- Newly diagnosed (prior to treatment) with esophageal and/or gastroesophageal junctional cancer (adeno- or squamous cell carcinoma)
- Planning to undergo curative treatment, including surgical resection with or without neoadjuvant therapy
Who cannot join
- Patients with the following characteristics will not be eligible for inclusion in this study:
- Pregnant females
- Without malignant esophageal disease
- Inability or unwillingness to provided informed written consent
Trial locations and contacts
1 site in 1 country.
United States1 site
Virginia Mason Medical Center
Seattle, Washington, 98101
About this study
Official title: Influence of Nutrition and SarcoPenia on Esophageal Cancer ouTcomes (INSPECT Study)
Prospective multicenter longitudinal (observational) study recruiting from tertiary centers for the surgical management of esophageal cancer; Virginia Mason Medical Center (Seattle, USA) and St Mary's Hospital (Imperial College, London, UK). This is intended to be a pilot study.
Read the detailed description
Patients undergoing curative treatment for esophageal cancer will be recruited at the time of routine clinical assessment shortly following initial diagnosis and will undergo clinical and radiological evaluation at two study time points: (1) staging investigation (e.g. laparoscopy or endoscopy) and (2) definitive surgical resection. Study time points have been judiciously chosen to coincide with interventions that form part of patient's routine clinical care. It is intended that sampling will occur on the day of each intervention/surgery following a routine period of fasting.
- Conditions
- Esophageal Cancer, Sarcopenia
- Medical subject headings
- Esophageal Neoplasms, Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Body Composition | Radiologic assessment of fat and muscle components of body composition at presentation and following initial treatment for esophageal cancer. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Longitudinal variation in body composition
Establish the effect of patient and disease-specific factors on body composition in a global cohort of patients undergoing esophagectomy for cancer
Measured: Approximately 1 year
Secondary outcomes (1)
Patient and disease-specific factors
Provide a benchmark for future reporting of body composition and to explore the association between body composition and outcomes of esophageal cancer surgery
Measured: Approximately 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2024
- Study start27 Dec 2017
- Primary completion28 Feb 2024
- Study completion28 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal 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
- Retrospective
- Enrolment
- 1,717 participants (actual)
Sponsor and investigators
- Lead sponsor
- Benaroya Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Imperial College London
- Responsible party
- Sponsor
- Investigators
- Donald E Low, MD, Principal investigator, Virginia Mason Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06314516
- Sponsor's protocol ID
- CRP17122
- Acronym
- INSPECT
- Status last verified
- Mar 2024
- First submitted
- 11 Mar 2024
- Last updated
- 24 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Patient characteristics will be pulled out by three regions, North America, Europe and Asia. Additional anonymized data may be available upon request.
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Nutrition and SarcoPenia on Esophageal Cancer ouTcomes (INSPECT Study)
- ClinicalTrials.gov ID
- NCT06314516
- Acronym / sponsor ID
- INSPECT / CRP17122
- Conditions
- Esophageal Cancer, Sarcopenia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,717 participants (actual)
- Lead sponsor
- Benaroya Research InstituteUniversity, hospital or other
- Collaborators
- Imperial College London
- Study start
- 27 Dec 2017 (actual)
- Primary completion
- 28 Feb 2024 (actual)
- Study completion
- 28 Feb 2024 (actual)
- First posted
- 18 Mar 2024 (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.
Prospective multicenter longitudinal (observational) study recruiting from tertiary centers for the surgical management of esophageal cancer; Virginia Mason Medical Center (Seattle, USA) and St Mary's Hospital (Imperial College, London, UK). This is intended to be a pilot study.
Detailed description
Patients undergoing curative treatment for esophageal cancer will be recruited at the time of routine clinical assessment shortly following initial diagnosis and will undergo clinical and radiological evaluation at two study time points: (1) staging investigation (e.g. laparoscopy or endoscopy) and (2) definitive surgical resection. Study time points have been judiciously chosen to coincide with interventions that form part of patient's routine clinical care. It is intended that sampling will occur on the day of each intervention/surgery following a routine period of fasting.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Body Composition | – | –Radiologic assessment of fat and muscle components of body composition at presentation and following initial treatment for esophageal cancer. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- International cohort of patients presenting with regional {Stage 2 and 3} esophageal cancer who are considered appropriate candidates for surgical therapy.
Key inclusion criteria (4 listed)
- Patients with the following characteristics will be eligible for inclusion in this study:
Key exclusion criteria (4 listed)
- Patients with the following characteristics will not be eligible for inclusion in this study:
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
Longitudinal variation in body composition
Time frame: Approximately 1 year
Establish the effect of patient and disease-specific factors on body composition in a global cohort of patients undergoing esophagectomy for cancer
1 secondary outcome
Patient and disease-specific factors
Time frame: Approximately 1 year
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 24 May 2024.
- Individual participant dataSharing planned: No. Patient characteristics will be pulled out by three regions, North America, Europe and Asia. Additional anonymized data may be available upon request.
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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.
Donald E Low, MD principal investigator
Virginia Mason Medical Center
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 Esophageal Cancer and Sarcopenia, run by Benaroya Research Institute at 1 site in United States.
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 4 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 24 May 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 States. 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?
Longitudinal variation in body composition (time frame: Approximately 1 year). 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 24 May 2024.