CancerETRENCT04994730
Exenteration: Quality of Life Study and Rehabilitation Rate According to the Reconstruction Technique (ETRE)
An observational study of Cancer, run by Institut Curie at 1 site in France.
Trial summary
Prospective monocentric quality of life study. Including all patients who have been exentered at the Institut Curie Paris, from January 2004 to December 2019, proposing to compare the reported quality of life of patients according to the reconstruction technique they have undergone. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Cancer
- What is being tested?
- Quality of life according to the reconstruction technique
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 118 participants
- Where
- 1 siteFrance
- Study dates
- 25 May 2021to 25 May 2022
- 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: All patients, living or lost, exentered at the Institut Curie Paris between January 2014 and December 2019,
Who may be able to join
- All patients, living or lost, exentered at the Institut Curie Paris between January 2014 and December 2019,
Who cannot join
- Persons under court protection.
- Persons not in a condition to give their consent.
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Institut Curie
Paris, 75005
Nathalie BADOIS, MD, +33156245765, nathalie.badois@curie.fr
Sandra NESPOULOUS, +33 147111654, drci.promotion@curie.fr
About this study
Official title: Exenteration: Quality of Life Study and Rehabilitation Rate According to the Reconstruction Technique
Prospective monocentric quality of life study. Including all patients who have been exentered at the Institut Curie Paris, from January 2004 to December 2019, proposing to compare the reported quality of life of patients according to the reconstruction technique they have undergone.
The sponsor will evaluate the quality of life of our patients by means of two validated questionnaires, in French, in the context of ENT surgery: the FACT-G and FACT-MBIS questionnaires.
Read the detailed description
It is now obvious to all surgeons involved in the follow-up of these patients that not all orbital reconstruction techniques are equal.
Thus, through this study, The investigators wish to objectively highlight the gain in quality of life and prosthetic equipment in exentered patients, depending on the reconstruction method used.
This prospective study, including all patients who have been exentered at the Institut Curie Paris, from January 2004 to December 2019, proposes to compare the reported quality of life of patients according to the reconstruction technique patients have undergone.
The investigators will evaluate the quality of life of our patients by means of two validated questionnaires, in French, in the context of ENT surgery: the FACT-G and FACT-MBIS questionnaires. The investigators will submit them, after express telephone agreement, by post to all the patients included in our study.
The aim of such a study will therefore be to provide assistance to both surgeons and patients in the choice of an orbital reconstruction technique, by objectively demonstrating the superiority of one technique over the others in terms of quality of life and prosthetic equipment rate.
The patients included in this study will have to answer two questionnaires, submitted by post. This study therefore falls within the framework of minimal or moderate risk studies.
The patients will be informed by telephone interview about the method of writing the questionnaires and their content.
The investigators will pay particular attention to the quality of life of the patients who have benefited from a free ante-brachial flap reconstruction in comparison with other reconstruction techniques; this will constitute the main criterion of our study.
In addition, the collection of pseudo-anonymised computerised data from all the patient files will give rise to a comparison of post-operative healing times, the rate of prosthetic fitting, and the time taken to fit the prosthesis according to the reconstruction techniques. These three factors, already identified in the literature as indicators of good rehabilitationn , will constitute our secondary judgment criteria.
- Conditions
- Cancer
- Being tested
- Quality of life according to the reconstruction technique
- Keywords
- Exenteration, Surgery, Quality of life
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quality of life according to the reconstruction techniqueBehavioural
For this retrospective analysis, 118 patients could be included, 17 of whom had undergone ante-brachial free flap reconstruction, 16 of whom had undergone this reconstruction within the last 2 years.
The primary endpoint: Analysis of the quality of life score according to the reconstruction technique (free ante-brachial flap versus others) will be performed by a Wilcoxon-Mann-Whitney test.
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional Assessment of Cancer Therapy: General (FACT-G)
The FACT-G questionnaire consists of 27 general items, with the patient scoring each item on a scale of 0 to 4. The final score is the sum of all the items.
Measured: Baseline
FACT/McGill Body Image Concern Scale - Head and Neck Cancer Version (FACT-MBIS)
The FACT-MBIS questionnaire consists of 21 items related to self-esteem and social comfort, each item is also scored on a scale of 0 to 4. The final score is the sum of all items.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2021
- Study start25 May 2021
- Primary completion25 May 2022 (estimated)
- Study completion25 May 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- 118 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institut Curie
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nathalie BADOIS, MD, Principal investigator, Institut Curie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04994730
- Sponsor's protocol ID
- IC 2020-14
- Acronym
- ETRE
- Status last verified
- Aug 2021
- First submitted
- 3 Aug 2021
- Last updated
- 31 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exenteration: Quality of Life Study and Rehabilitation Rate According to the Reconstruction Technique
- ClinicalTrials.gov ID
- NCT04994730
- Acronym / sponsor ID
- ETRE / IC 2020-14
- Conditions
- Cancer
- Keywords
- Exenteration, Surgery, Quality of life
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 118 participants (estimated)
- Lead sponsor
- Institut CurieUniversity, hospital or other
- Study start
- 25 May 2021 (actual)
- Primary completion
- 25 May 2022 (estimated)
- Study completion
- 25 May 2022 (estimated)
- First posted
- 6 Aug 2021 (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 monocentric quality of life study. Including all patients who have been exentered at the Institut Curie Paris, from January 2004 to December 2019, proposing to compare the reported quality of life of patients according to the reconstruction technique they have undergone.
The sponsor will evaluate the quality of life of our patients by means of two validated questionnaires, in French, in the context of ENT surgery: the FACT-G and FACT-MBIS questionnaires.
Detailed description
It is now obvious to all surgeons involved in the follow-up of these patients that not all orbital reconstruction techniques are equal.
Thus, through this study, The investigators wish to objectively highlight the gain in quality of life and prosthetic equipment in exentered patients, depending on the reconstruction method used.
This prospective study, including all patients who have been exentered at the Institut Curie Paris, from January 2004 to December 2019, proposes to compare the reported quality of life of patients according to the reconstruction technique patients have undergone.
The investigators will evaluate the quality of life of our patients by means of two validated questionnaires, in French, in the context of ENT surgery: the FACT-G and FACT-MBIS questionnaires. The investigators will submit them, after express telephone agreement, by post to all the patients included in our study.
The aim of such a study will therefore be to provide assistance to both surgeons and patients in the choice of an orbital reconstruction technique, by objectively demonstrating the superiority of one technique over the others in terms of quality of life and prosthetic equipment rate.
The patients included in this study will have to answer two questionnaires, submitted by post. This study therefore falls within the framework of minimal or moderate risk studies.
The patients will be informed by telephone interview about the method of writing the questionnaires and their content.
The investigators will pay particular attention to the quality of life of the patients who have benefited from a free ante-brachial flap reconstruction in comparison with other reconstruction techniques; this will constitute the main criterion of our study.
In addition, the collection of pseudo-anonymised computerised data from all the patient files will give rise to a comparison of post-operative healing times, the rate of prosthetic fitting, and the time taken to fit the prosthesis according to the reconstruction techniques. These three factors, already identified in the literature as indicators of good rehabilitationn , will constitute our secondary judgment criteria.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients, living or lost, exentered at the Institut Curie Paris between January 2014 and December 2019,
Key inclusion criteria (1 listed)
- All patients, living or lost, exentered at the Institut Curie Paris between January 2014 and December 2019,
Key exclusion criteria (2 listed)
- Persons under court protection.
- Persons not in a condition to give their consent.
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 |
|---|---|---|
| Quality of life according to the reconstruction techniqueFor this retrospective analysis, 118 patients could be included, 17 of whom had undergone ante-brachial free flap reconstruction, 16 of whom had undergone this reconstruction within the last 2 years. The primary endpoint: Analysis of the quality of life score according to the reconstruction technique (free ante-brachial flap versus others) will be performed by a Wilcoxon-Mann-Whitney test. | Behavioural | – |
Primary outcome
Functional Assessment of Cancer Therapy: General (FACT-G)
Time frame: Baseline
The FACT-G questionnaire consists of 27 general items, with the patient scoring each item on a scale of 0 to 4. The final score is the sum of all the items.
FACT/McGill Body Image Concern Scale - Head and Neck Cancer Version (FACT-MBIS)
Time frame: Baseline
The FACT-MBIS questionnaire consists of 21 items related to self-esteem and social comfort, each item is also scored on a scale of 0 to 4. The final score is the sum of all items.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2021.
- Individual participant dataSharing planned: No
Related trials for Cancer
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
RecruitingPhase 2
Tafasitamab With Acalabrutinib and Venetoclax for the Treatment of Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Chronic Lymphocytic Leukemia, Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Active, not recruitingPhase 1/2
Selumetinib in Treating Young Patients With Recurrent or Refractory Low Grade Glioma
Low Grade Glioma, Recurrent Childhood Pilocytic Astrocytoma
Enrolling by invitationPhase 2
A Single-Arm Study of Nimotuzumab Combined With NALIRIFOX as First-Line Treatment for Pancreatic Cancer
Pancreatic Cancer Metastatic
Recruiting
Methylation Profiling in Self-Samples for Identification of (Epi)Genetic Biomarkers for Gynecological Cancers
Gynaecological Cancers, Ovarian Cancer
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.
Nathalie BADOIS, MD principal investigator
Institut Curie
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 Cancer, run by Institut Curie at 1 site in France.
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 2 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 31 Aug 2021. 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 France. 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 Nathalie BADOIS, MD (+33144324535, nathalie.badois@curie.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional Assessment of Cancer Therapy: General (FACT-G) (time frame: Baseline). The study lists 2 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 31 Aug 2021.