Gastrointestinal Carcinoid TumorNCT00454376
Disease-Specific Questionnaire in Assessing Quality of Life in Patients With Gastrointestinal-Related Neuroendocrine Tumors
An observational study of Gastrointestinal Carcinoid Tumor and Islet Cell Tumor, run by National Cancer Institute (NCI) at 16 sites in 10 countries.
Trial summary
RATIONALE: Questionnaires that measure quality of life may help doctors identify the effects of treatment and improve the ability to plan treatment for patients with gastrointestinal-related neuroendocrine tumors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastrointestinal Carcinoid Tumor, Islet Cell Tumor, Lung Cancer
- What is being tested?
- questionnaire administration and quality-of-life assessment
- Type of treatment
- Surgery or procedure
- How many people
- 408 participants
- Where
- 16 sitesin 10 countries
- Study dates
- Oct 2006to not given
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS:
- Histologically confirmed neuroendocrine tumor OR characteristic radiological findings of neuroendocrine tumor with raised hormone levels in plasma or urine meeting any of the following criteria:
- Primary disease in gut with liver metastases (with or without hormone secretion)
- Primary disease in lung with liver or abdominal metastases (with or without hormone secretion)
- Primary disease in pancreas with or without metastases (with or without hormone secretion)
PATIENT CHARACTERISTICS:
- Any Karnofsky performance status allowed
- Life expectancy ≥ 3 months
- Able to understand the questionnaire language
- Mentally fit to complete questionnaire
- No psychological, familial, sociological, or geographical condition that would limit study compliance
- No other concurrent malignancies except basal cell carcinoma of the skin
PRIOR CONCURRENT THERAPY:
- More than 2 months since prior somatostatin analogue or interferon therapy (somatostatin therapy stratum)
- Concurrent somatostatin analogue and/or interferon therapy allowed if dose stable over the past month
- More than 6 months since prior radionuclide therapy or systemic chemotherapy (radionuclide or systemic chemotherapy stratum)
- More than 6 months since prior ablative therapies (ablative therapy stratum)
- No concurrent participation in other quality of life studies
Trial locations and contacts
16 sites in 10 countries.
16 sites in 10 countries
United Kingdom6 sites
Basingstoke and North Hampshire NHS Foundation Trust
Basingstoke, England, RG24 9NA
Royal Victoria Hospital
Belfast, Northern Ireland, BT12 6BA
Aintree University Hospital
Liverpool, England, L9 7AL
UCL Cancer Institute
London, England, NW1 2QG
King's College Hospital
London, England, SE5 9RS
Southampton General Hospital
Southampton, England, SO16 6YD
Germany2 sites
Charite - Campus Charite Mitte
Berlin, D-10117
Klinikum der Universitaet Regensburg
Regensburg, D-93053
Italy1 site
Clinical and Experimental Medicine at the University of Verona
Verona, 37129
Netherlands1 site
Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital
Amsterdam, 1066 CX
Poland1 site
Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology - Warsaw
Warsaw, 02-781
About this study
Official title: Clinical and Psychometric Validation of a Disease-Specific Questionnaire Module in Assessing the Quality of Life of Patients With G.I.-Related Neuroendocrine Tumours
RATIONALE: Questionnaires that measure quality of life may help doctors identify the effects of treatment and improve the ability to plan treatment for patients with gastrointestinal-related neuroendocrine tumors.
PURPOSE: This phase IV clinical trial is studying how well a disease-specific questionnaire works in assessing the quality of life of patients with gastrointestinal-related neuroendocrine tumors.
Read the detailed description
OBJECTIVES:
Primary
- Test the scale structure, reliability, and validity of the gastrointestinal neuroendocrine tumor module (QLQ-G.I.NET21) in patients with gastrointestinal-related neuroendocrine tumors.
Secondary
- Determine the quality of life of patients using QLQ-C30 and the QLQ-G.I.NET21 before and after treatment.
OUTLINE: This is a multicenter study. Patients are stratified according to treatment (somatostatin analogue therapy or interferon therapy vs radionuclide therapy or chemotherapy vs ablative therapies [embolization or radiofrequency ablation] or liver resection).
Patients complete the EORTC C30 questionnaire, QLQ-G.I.NET21 module, and are evaluated for Karnofsky performance status at pretreatment, at 3 and 6 months after treatment, and then 2 weeks later. Patients also complete a clinical data and sociodemographic data form and debriefing questionnaire at pretreatment; a follow-up form at 3 months and 6 months after treatment; and a test-retest form 2 weeks later.
PROJECTED ACCRUAL: A total of 408 patients will be accrued for this study.
- Conditions
- Gastrointestinal Carcinoid Tumor, Islet Cell Tumor, Lung Cancer, Metastatic Cancer, Neoplastic Syndrome
- Being tested
- questionnaire administration, quality-of-life assessment
- Keywords
- metastatic gastrointestinal carcinoid tumor, recurrent gastrointestinal carcinoid tumor, pulmonary carcinoid tumor, gastrinoma, insulinoma, WDHA syndrome, pancreatic polypeptide tumor, somatostatinoma, glucagonoma, liver metastases
- Medical subject headings
- Adenoma, Islet Cell, Lung Neoplasms, Neoplasm Metastasis, Neoplasms, Gastrinoma, Insulinoma, Vipoma, Somatostatinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
questionnaire administrationOther
quality-of-life assessmentProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Reliability, scaling, scale correlation, and clinical validity of the gastrointestinal neuroendocrine tumor module (QLQ-G.I.NET21)
Secondary outcomes (1)
Response to change after various treatments
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2007 (estimated)
- Study startOct 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastrointestinal Carcinoid TumorStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The 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
- Observational
- Enrolment
- 408 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Investigators
- John K. Ramage, MD, Study chair, Basingstoke and North Hampshire NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00454376
- Sponsor's protocol ID
- CDR0000537344
- Other IDs
- EORTC-QLQ-G.I.NET21, EU-20712, BNHFT-P4NET, EU-207101
- Status last verified
- Nov 2008
- First submitted
- 27 Mar 2007
- Last updated
- 29 Oct 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Psychometric Validation of a Disease-Specific Questionnaire Module in Assessing the Quality of Life of Patients With G.I.-Related Neuroendocrine Tumours
- ClinicalTrials.gov ID
- NCT00454376
- Acronym / sponsor ID
- CDR0000537344
- Conditions
- Gastrointestinal Carcinoid Tumor, Islet Cell Tumor, Lung Cancer, Metastatic Cancer, Neoplastic Syndrome
- Keywords
- metastatic gastrointestinal carcinoid tumor, recurrent gastrointestinal carcinoid tumor, pulmonary carcinoid tumor, gastrinoma, insulinoma, WDHA syndrome, pancreatic polypeptide tumor, somatostatinoma
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 408 participants (estimated)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- Oct 2006
- First posted
- 30 Mar 2007 (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.
RATIONALE: Questionnaires that measure quality of life may help doctors identify the effects of treatment and improve the ability to plan treatment for patients with gastrointestinal-related neuroendocrine tumors.
PURPOSE: This phase IV clinical trial is studying how well a disease-specific questionnaire works in assessing the quality of life of patients with gastrointestinal-related neuroendocrine tumors.
Detailed description
OBJECTIVES:
Primary
- Test the scale structure, reliability, and validity of the gastrointestinal neuroendocrine tumor module (QLQ-G.I.NET21) in patients with gastrointestinal-related neuroendocrine tumors.
Secondary
- Determine the quality of life of patients using QLQ-C30 and the QLQ-G.I.NET21 before and after treatment.
OUTLINE: This is a multicenter study. Patients are stratified according to treatment (somatostatin analogue therapy or interferon therapy vs radionuclide therapy or chemotherapy vs ablative therapies [embolization or radiofrequency ablation] or liver resection).
Patients complete the EORTC C30 questionnaire, QLQ-G.I.NET21 module, and are evaluated for Karnofsky performance status at pretreatment, at 3 and 6 months after treatment, and then 2 weeks later. Patients also complete a clinical data and sociodemographic data form and debriefing questionnaire at pretreatment; a follow-up form at 3 months and 6 months after treatment; and a test-retest form 2 weeks later.
PROJECTED ACCRUAL: A total of 408 patients will be accrued for this study.
Study design
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| questionnaire administration | Other | – |
| quality-of-life assessment | Procedure or surgery | – |
Primary outcome
Reliability, scaling, scale correlation, and clinical validity of the gastrointestinal neuroendocrine tumor module (QLQ-G.I.NET21)
1 secondary outcome
Response to change after various treatments
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 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.
John K. Ramage, MD study chair
Basingstoke and North Hampshire NHS Foundation Trust
16 sites in 10 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gastrointestinal Carcinoid Tumor and Islet Cell Tumor, run by National Cancer Institute (NCI) at 16 sites in 10 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 29 Oct 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in United Kingdom, Germany, Denmark, Greece, Israel and 5 more countries. 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?
Reliability, scaling, scale correlation, and clinical validity of the gastrointestinal neuroendocrine tumor module (QLQ-G.I.NET21). 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 29 Oct 2013.