SurgerySURGprofilNCT05865964
Anthropological, Socio-cultural and Psychological Surgeons' Factors in Oncology and Brakes for Evaluation of Innovations
An observational study of Surgery, run by Institut Claudius Regaud at 1 site in France.
Trial summary
The field of surgery continues to benefit from innovative solutions, changing surgical methods and techniques. Evaluation in terms of efficacy and Quality-Safety is an essential topic that directly affects the introduction of innovations. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Surgery
- How many people
- 260 participants
- Where
- 1 siteFrance
- Study dates
- 14 Dec 2022to 25 May 2026
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Surgeon practising oncology in France.
Who may be able to join
- Surgeon practising oncology in France.
- E-mail address accessible via one of the companies/cooperating groups that have agreed to participate in the project
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Anthropological, Socio-cultural and Psychological Factors of Surgeons Practising in Oncology Which Condition Brakes in the Evaluation of Surgical Innovations
The field of surgery continues to benefit from innovative solutions, changing surgical methods and techniques. Evaluation in terms of efficacy and Quality-Safety is an essential topic that directly affects the introduction of innovations. It is essential to carry out a robust evaluation strategy for surgical innovations, even if these are often opposed to drug innovations. The aim of this study is to investigate the anthropological, socio-cultural and psychological differences of surgeons that influence the evaluation of surgical innovations.
Read the detailed description
RESEARCH HYPOTHESIS Over the past decade, the role of the surgeon in scientific research in oncology has evolved and many surgeons are involved in basic research activities alongside their clinical activities. Despite this increasing involvement in research, the issue of evaluation of surgical procedures remains a major concern. As an example, the French Society of Oncological Surgery programs at its annual congress a plenary session "Randomized trial: the grail in oncological surgery?". When the topic of clinical research is discussed, one of the first reactions is usually to point out the differences between research on new therapies and on surgical procedures. This persistent claim can be challenged. This claim may also be related to the major difference in regulation between therapeutics (MA) and medical devices (CE markings) which may not have encouraged surgeons to develop the culture of randomised evidence.
No study seems to evaluate the factors related to the surgeon influencing his involvement and participation in clinical research in oncological surgery. The aim of our study is to determine which anthropo-sociological factors in surgeons are associated with the obstacles to the evaluation of surgical innovations and influence their degree of participation in clinical research.
OBJECTIVES OF THE STUDY The main objective of this study is to evaluate the factors associated with the obstacles to the evaluation of surgical innovations.
The secondary objectives are :
- To identify the factors associated with involvement in clinical research on two levels : (i) Investigator coordinator, (ii) Investigator in a study.
- To assess knowledge of complementary designs to the randomised trial.
- To identify the parameters associated with 'knowledge' of the complementary regimens to the randomised trial.
STUDY DESIGN This is a prospective study conducted on a national scale in the form of a survey of surgeons working in cancerology. This project has obtained the support of UNICANCER (Federation of Cancer Centres), the French-speaking Society of Oncological Surgery (SFCO), the Head and Neck Tumour Study Group (GETTEC), the French Society of Cervico-facial Carcinology (SFCCF), French Society of Gynecology Oncology (SFOG), French Association of Digestive \& Visceral Surgery and the French Society of Thoracic and Cardiovascular Surgery. Their mailings will be used to disseminate the survey to surgeons in the area.
STUDY PROCESS
Phase 1: Questionnaire creation
The first part of the project will consist in the creation of the questionnaire. The questionnaire will include data related to the surgeon (non-exhaustive list):
- Demography: age, gender
- Education :
- Place and date of graduation from medical school,
- Obtained DESC in oncology or European equivalent
- Practice :
- Speciality: senology, gynaecology,...
- Main place of practice: CHU, CLCC, CHG, Private clinic, ESPIC outside CLCC, Other,
- Number of treated patients per year.
- Involvement in clinical research:
- Accreditation to GCP Validated,
- Number of trials as Coordinating Investigator / Principal Investigator,
- Number of patients included in a clinical trial per year,
- Member of a learned society or cooperative group,
Questions associated with barriers to conducting trials in surgery and alternative methodological approaches will be drafted.
Practitioners' attitudes towards risk and uncertainty will be assessed by the following tools:
- Questions on willingness to take risk in general and in different areas (answers given on a scale of 0-10).
- Questions on the willingness to engage in risky activities in different areas (answers given on a scale of 0-10).
- Choice of lotteries : choice between 6 lotteries characterised by different payoffs and risk levels.
In order to check the feasibility, the online questionnaire will be evaluated by the steering committee. The steering committee will include members from the sponsoring centre but also external members who will not be involved in the creation of the questionnaire. Once the questionnaire has been developed, the regulatory steps will be taken.
Phase 2: Awareness raising In this type of study, one of the key points is the response to the questionnaires. In order to mobilise a maximum of surgeons, actions (presentation, Webinar) will be carried out with the different groups/companies that have agreed to participate in the projects.
Phase 3: Sending of questionnaires The questionnaires will be sent to the different surgeons via the Sphynx survey software. This software allows the distribution of dynamic and interactive questionnaires with a display adapted to different media (computer, tablet, smartphone, etc.).
STATISTICAL METHODOLOGY Number of participants needed In two previous studies with a similar methodology, a response rate with usable questionnaires of 17 to 30% was observed, corresponding to 200 and 230 questionnaires. With 200 usable questionnaires and assuming that for 50% of them, obstacles to the evaluation of surgical innovations are identified, it is possible to carry out a multivariable model with 12 parameters according to the rule of thumb of 10 events per variable.
Statistical analysis Demographic data will be described by the usual descriptive statistics. Categorical variables will be presented as follows: number of missing data, number and percentage for each modality of the variable. Quantitative data will be presented as follows: median, minimum, maximum, number of missing data.
- Conditions
- Surgery
- Keywords
- Medical Care, clinical trial, innovation, breaks, surgeons, oncology
- Medical subject headings
- Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Identification of the parameters associated with barriers to the evaluation of surgical innovations.
Logistic regression modelling will be carried out to identify the parameters associated with barriers to the evaluation of surgical innovations.
The odds ratios will be estimated with their 95% confidence intervals. In accordance with the recommendations of the literature, a top-down stepwise procedure will be performed for the selection of variables.
Measured: 21 months
Secondary outcomes (2)
Identification of the parameters associated with involvement in clinical research.
Logistic regression modelling will be carried out to identify the parameters associated with involvement in clinical research.
The odds ratios will be estimated with their 95% confidence intervals. In accordance with the recommendations of the literature, a top-down stepwise procedure will be performed for the selection of variables.
Measured: 21 months
Identification of the parameters associated with knowledge of complementary patterns.
Knowledge of complementary patterns to the randomised trial will be presented using standard descriptive statistics. A similar strategy to the analysis of the primary objective will be used to identify parameters associated with knowledge of complementary patterns.
Measured: 21 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2023
- Study start14 Dec 2022
- Primary completion25 May 2026
- Study completion25 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (33)Papers the sponsor has linked to this study.
- Other trials for SurgeryStudies 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
- 260 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut Claudius Regaud
- Sponsor type
- University, hospital or other
- Collaborators
- West Cancerology Institute, France, Toulouse Capitole University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05865964
- Sponsor's protocol ID
- 22RD14
- Acronym
- SURGprofil
- Status last verified
- Jun 2026
- First submitted
- 10 May 2023
- Last updated
- 11 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bories P, Lamy S, Simand C, Bertoli S, Delpierre C, Malak S, Fornecker L, Moreau S, Recher C, Nebout A. Physician uncertainty aversion impacts medical decision making for older patients with acute myeloid leukemia: results of a national survey. Haematologica. 2018 Dec;103(12):2040-2048. doi: 10.3324/haematol.2018.192468. Epub 2018 Jul 13.
PubMed 30006448Brandberg Y, Malm M, Blomqvist L. A prospective and randomized study, "SVEA," comparing effects of three methods for delayed breast reconstruction on quality of life, patient-defined problem areas of life, and cosmetic result. Plast Reconstr Surg. 2000 Jan;105(1):66-74; discussion 75-6. doi: 10.1097/00006534-200001000-00011.
PubMed 10626972Castel P, Negrier S, Boissel JP; Plateforme d'Aide a la Recherche Clinique en Cancerologie de la region Rhone-Alpes. Why don't cancer patients enter clinical trials? A review. Eur J Cancer. 2006 Aug;42(12):1744-8. doi: 10.1016/j.ejca.2005.10.033. Epub 2006 Jun 14.
PubMed 16777404Concato J, Peduzzi P, Holford TR, Feinstein AR. Importance of events per independent variable in proportional hazards analysis. I. Background, goals, and general strategy. J Clin Epidemiol. 1995 Dec;48(12):1495-501. doi: 10.1016/0895-4356(95)00510-2.
PubMed 8543963Cook JA. The challenges faced in the design, conduct and analysis of surgical randomised controlled trials. Trials. 2009 Feb 6;10:9. doi: 10.1186/1745-6215-10-9.
PubMed 19200379Crocker JC, Farrar N, Cook JA, Treweek S, Woolfall K, Chant A, Bostock J, Locock L, Rees S, Olszowski S, Bulbulia R. Recruitment and retention of participants in UK surgical trials: survey of key issues reported by trial staff. BJS Open. 2020 Oct 4;4(6):1238-45. doi: 10.1002/bjs5.50345. Online ahead of print.
PubMed 33016008Cros F, Lamy S, Grosclaude P, Nebout A, Chabrillac E, Vergez S, Bories P, Dupret-Bories A. Physician practice variation in head and neck cancer therapy: Results of a national survey. Oral Oncol. 2021 Jun;117:105293. doi: 10.1016/j.oraloncology.2021.105293. Epub 2021 Apr 14.
PubMed 33862559Elliott D, Hamdy FC, Leslie TA, Rosario D, Dudderidge T, Hindley R, Emberton M, Brewster S, Sooriakumaran P, Catto JWF, Emara A, Ahmed H, Whybrow P, le Conte S, Donovan JL. Overcoming difficulties with equipoise to enable recruitment to a randomised controlled trial of partial ablation vs radical prostatectomy for unilateral localised prostate cancer. BJU Int. 2018 Dec;122(6):970-977. doi: 10.1111/bju.14432. Epub 2018 Aug 15.
PubMed 29888845Evrard S, McKelvie-Sebileau P, van de Velde C, Nordlinger B, Poston G. What can we learn from oncology surgical trials? Nat Rev Clin Oncol. 2016 Jan;13(1):55-62. doi: 10.1038/nrclinonc.2015.176. Epub 2015 Oct 20.
PubMed 26483296Filleron T, Bonnetain F, Mancini J, Martinez A, Roche H, Dalenc F. Prospective construction and validation of a prognostic score to identify patients who benefit from third-line chemotherapy for metastatic breast cancer in terms of overall survival: the METAL3 Study. Contemp Clin Trials. 2015 Jan;40:1-8. doi: 10.1016/j.cct.2014.11.005. Epub 2014 Nov 8.
PubMed 25460338Filleron T, Lusque A, Dalenc F, Ferron G, Roche H, Martinez A, Jouve E. Alternative methodological approach to randomized trial for surgical procedures routinely used. Contemp Clin Trials. 2018 May;68:109-115. doi: 10.1016/j.cct.2018.03.016. Epub 2018 Mar 30.
PubMed 29608972Fisher B, Montague E, Redmond C, Barton B, Borland D, Fisher ER, Deutsch M, Schwarz G, Margolese R, Donegan W, Volk H, Konvolinka C, Gardner B, Cohn I Jr, Lesnick G, Cruz AB, Lawrence W, Nealon T, Butcher H, Lawton R. Comparison of radical mastectomy with alternative treatments for primary breast cancer. A first report of results from a prospective randomized clinical trial. Cancer. 1977 Jun;39(6 Suppl):2827-39. doi: 10.1002/1097-0142(197706)39:63.0.co;2-i. No abstract available.
PubMed 326381Ford E, Jenkins V, Fallowfield L, Stuart N, Farewell D, Farewell V. Clinicians' attitudes towards clinical trials of cancer therapy. Br J Cancer. 2011 May 10;104(10):1535-43. doi: 10.1038/bjc.2011.119. Epub 2011 Apr 12.
PubMed 21487408Giuliano AE, McCall L, Beitsch P, Whitworth PW, Blumencranz P, Leitch AM, Saha S, Hunt KK, Morrow M, Ballman K. Locoregional recurrence after sentinel lymph node dissection with or without axillary dissection in patients with sentinel lymph node metastases: the American College of Surgeons Oncology Group Z0011 randomized trial. Ann Surg. 2010 Sep;252(3):426-32; discussion 432-3. doi: 10.1097/SLA.0b013e3181f08f32.
PubMed 20739842Goyal A, Dodwell D. POSNOC: A Randomised Trial Looking at Axillary Treatment in Women with One or Two Sentinel Nodes with Macrometastases. Clin Oncol (R Coll Radiol). 2015 Dec;27(12):692-5. doi: 10.1016/j.clon.2015.07.005. Epub 2015 Aug 5. No abstract available.
PubMed 26254841
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Anthropological, Socio-cultural and Psychological Factors of Surgeons Practising in Oncology Which Condition Brakes in the Evaluation of Surgical Innovations
- ClinicalTrials.gov ID
- NCT05865964
- Acronym / sponsor ID
- SURGprofil / 22RD14
- Conditions
- Surgery
- Keywords
- Medical Care, clinical trial, innovation, breaks, surgeons, oncology
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 260 participants (actual)
- Lead sponsor
- Institut Claudius RegaudUniversity, hospital or other
- Collaborators
- West Cancerology Institute, France, Toulouse Capitole University
- Study start
- 14 Dec 2022 (actual)
- Primary completion
- 25 May 2026 (actual)
- Study completion
- 25 May 2026 (actual)
- First posted
- 19 May 2023 (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.
The field of surgery continues to benefit from innovative solutions, changing surgical methods and techniques. Evaluation in terms of efficacy and Quality-Safety is an essential topic that directly affects the introduction of innovations. It is essential to carry out a robust evaluation strategy for surgical innovations, even if these are often opposed to drug innovations. The aim of this study is to investigate the anthropological, socio-cultural and psychological differences of surgeons that influence the evaluation of surgical innovations.
Detailed description
RESEARCH HYPOTHESIS Over the past decade, the role of the surgeon in scientific research in oncology has evolved and many surgeons are involved in basic research activities alongside their clinical activities. Despite this increasing involvement in research, the issue of evaluation of surgical procedures remains a major concern. As an example, the French Society of Oncological Surgery programs at its annual congress a plenary session "Randomized trial: the grail in oncological surgery?". When the topic of clinical research is discussed, one of the first reactions is usually to point out the differences between research on new therapies and on surgical procedures. This persistent claim can be challenged. This claim may also be related to the major difference in regulation between therapeutics (MA) and medical devices (CE markings) which may not have encouraged surgeons to develop the culture of randomised evidence.
No study seems to evaluate the factors related to the surgeon influencing his involvement and participation in clinical research in oncological surgery. The aim of our study is to determine which anthropo-sociological factors in surgeons are associated with the obstacles to the evaluation of surgical innovations and influence their degree of participation in clinical research.
OBJECTIVES OF THE STUDY The main objective of this study is to evaluate the factors associated with the obstacles to the evaluation of surgical innovations.
The secondary objectives are :
- To identify the factors associated with involvement in clinical research on two levels : (i) Investigator coordinator, (ii) Investigator in a study.
- To assess knowledge of complementary designs to the randomised trial.
- To identify the parameters associated with 'knowledge' of the complementary regimens to the randomised trial.
STUDY DESIGN This is a prospective study conducted on a national scale in the form of a survey of surgeons working in cancerology. This project has obtained the support of UNICANCER (Federation of Cancer Centres), the French-speaking Society of Oncological Surgery (SFCO), the Head and Neck Tumour Study Group (GETTEC), the French Society of Cervico-facial Carcinology (SFCCF), French Society of Gynecology Oncology (SFOG), French Association of Digestive \& Visceral Surgery and the French Society of Thoracic and Cardiovascular Surgery. Their mailings will be used to disseminate the survey to surgeons in the area.
STUDY PROCESS
Phase 1: Questionnaire creation
The first part of the project will consist in the creation of the questionnaire. The questionnaire will include data related to the surgeon (non-exhaustive list):
- Demography: age, gender
- Education :
- Place and date of graduation from medical school,
- Obtained DESC in oncology or European equivalent
- Practice :
- Speciality: senology, gynaecology,...
- Main place of practice: CHU, CLCC, CHG, Private clinic, ESPIC outside CLCC, Other,
- Number of treated patients per year.
- Involvement in clinical research:
- Accreditation to GCP Validated,
- Number of trials as Coordinating Investigator / Principal Investigator,
- Number of patients included in a clinical trial per year,
- Member of a learned society or cooperative group,
Questions associated with barriers to conducting trials in surgery and alternative methodological approaches will be drafted.
Practitioners' attitudes towards risk and uncertainty will be assessed by the following tools:
- Questions on willingness to take risk in general and in different areas (answers given on a scale of 0-10).
- Questions on the willingness to engage in risky activities in different areas (answers given on a scale of 0-10).
- Choice of lotteries : choice between 6 lotteries characterised by different payoffs and risk levels.
In order to check the feasibility, the online questionnaire will be evaluated by the steering committee. The steering committee will include members from the sponsoring centre but also external members who will not be involved in the creation of the questionnaire. Once the questionnaire has been developed, the regulatory steps will be taken.
Phase 2: Awareness raising In this type of study, one of the key points is the response to the questionnaires. In order to mobilise a maximum of surgeons, actions (presentation, Webinar) will be carried out with the different groups/companies that have agreed to participate in the projects.
Phase 3: Sending of questionnaires The questionnaires will be sent to the different surgeons via the Sphynx survey software. This software allows the distribution of dynamic and interactive questionnaires with a display adapted to different media (computer, tablet, smartphone, etc.).
STATISTICAL METHODOLOGY Number of participants needed In two previous studies with a similar methodology, a response rate with usable questionnaires of 17 to 30% was observed, corresponding to 200 and 230 questionnaires. With 200 usable questionnaires and assuming that for 50% of them, obstacles to the evaluation of surgical innovations are identified, it is possible to carry out a multivariable model with 12 parameters according to the rule of thumb of 10 events per variable.
Statistical analysis Demographic data will be described by the usual descriptive statistics. Categorical variables will be presented as follows: number of missing data, number and percentage for each modality of the variable. Quantitative data will be presented as follows: median, minimum, maximum, number of missing data.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Surgeon practising oncology in France.
Key inclusion criteria (2 listed)
- Surgeon practising oncology in France.
- E-mail address accessible via one of the companies/cooperating groups that have agreed to participate in the project
Key exclusion criteria (1 listed)
- None
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
Identification of the parameters associated with barriers to the evaluation of surgical innovations.
Time frame: 21 months
Logistic regression modelling will be carried out to identify the parameters associated with barriers to the evaluation of surgical innovations. The odds ratios will be estimated with their 95% confidence intervals. In accordance with the recommendations of the literature, a top-down stepwise procedure will be performed for the selection of variables.
2 secondary outcomes
Identification of the parameters associated with involvement in clinical research.
Time frame: 21 months
Identification of the parameters associated with knowledge of complementary patterns.
Time frame: 21 months
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 11 Sep 2026.
- Background: PubMed 30006448Bories P, Lamy S, Simand C, Bertoli S, Delpierre C, Malak S, Fornecker L, Moreau S, Recher C, Nebout A. Physician uncertainty aversion impacts medical decision making for older patients with acute myeloid leukemia: results of a national survey. Haematologica. 2018 Dec;103(12):2040-2048. doi: 10.3324/haematol.2018.192468. Epub 2018 Jul 13.
- Background: PubMed 10626972Brandberg Y, Malm M, Blomqvist L. A prospective and randomized study, "SVEA," comparing effects of three methods for delayed breast reconstruction on quality of life, patient-defined problem areas of life, and cosmetic result. Plast Reconstr Surg. 2000 Jan;105(1):66-74; discussion 75-6. doi: 10.1097/00006534-200001000-00011.
- Background: PubMed 16777404Castel P, Negrier S, Boissel JP; Plateforme d'Aide a la Recherche Clinique en Cancerologie de la region Rhone-Alpes. Why don't cancer patients enter clinical trials? A review. Eur J Cancer. 2006 Aug;42(12):1744-8. doi: 10.1016/j.ejca.2005.10.033. Epub 2006 Jun 14.
- Background: PubMed 8543963Concato J, Peduzzi P, Holford TR, Feinstein AR. Importance of events per independent variable in proportional hazards analysis. I. Background, goals, and general strategy. J Clin Epidemiol. 1995 Dec;48(12):1495-501. doi: 10.1016/0895-4356(95)00510-2.
- Background: PubMed 19200379Cook JA. The challenges faced in the design, conduct and analysis of surgical randomised controlled trials. Trials. 2009 Feb 6;10:9. doi: 10.1186/1745-6215-10-9.
- Background: PubMed 33016008Crocker JC, Farrar N, Cook JA, Treweek S, Woolfall K, Chant A, Bostock J, Locock L, Rees S, Olszowski S, Bulbulia R. Recruitment and retention of participants in UK surgical trials: survey of key issues reported by trial staff. BJS Open. 2020 Oct 4;4(6):1238-45. doi: 10.1002/bjs5.50345. Online ahead of print.
- Background: PubMed 33862559Cros F, Lamy S, Grosclaude P, Nebout A, Chabrillac E, Vergez S, Bories P, Dupret-Bories A. Physician practice variation in head and neck cancer therapy: Results of a national survey. Oral Oncol. 2021 Jun;117:105293. doi: 10.1016/j.oraloncology.2021.105293. Epub 2021 Apr 14.
- Background: PubMed 29888845Elliott D, Hamdy FC, Leslie TA, Rosario D, Dudderidge T, Hindley R, Emberton M, Brewster S, Sooriakumaran P, Catto JWF, Emara A, Ahmed H, Whybrow P, le Conte S, Donovan JL. Overcoming difficulties with equipoise to enable recruitment to a randomised controlled trial of partial ablation vs radical prostatectomy for unilateral localised prostate cancer. BJU Int. 2018 Dec;122(6):970-977. doi: 10.1111/bju.14432. Epub 2018 Aug 15.
- Background: PubMed 26483296Evrard S, McKelvie-Sebileau P, van de Velde C, Nordlinger B, Poston G. What can we learn from oncology surgical trials? Nat Rev Clin Oncol. 2016 Jan;13(1):55-62. doi: 10.1038/nrclinonc.2015.176. Epub 2015 Oct 20.
- Background: PubMed 25460338Filleron T, Bonnetain F, Mancini J, Martinez A, Roche H, Dalenc F. Prospective construction and validation of a prognostic score to identify patients who benefit from third-line chemotherapy for metastatic breast cancer in terms of overall survival: the METAL3 Study. Contemp Clin Trials. 2015 Jan;40:1-8. doi: 10.1016/j.cct.2014.11.005. Epub 2014 Nov 8.
- Background: PubMed 29608972Filleron T, Lusque A, Dalenc F, Ferron G, Roche H, Martinez A, Jouve E. Alternative methodological approach to randomized trial for surgical procedures routinely used. Contemp Clin Trials. 2018 May;68:109-115. doi: 10.1016/j.cct.2018.03.016. Epub 2018 Mar 30.
- Background: PubMed 326381Fisher B, Montague E, Redmond C, Barton B, Borland D, Fisher ER, Deutsch M, Schwarz G, Margolese R, Donegan W, Volk H, Konvolinka C, Gardner B, Cohn I Jr, Lesnick G, Cruz AB, Lawrence W, Nealon T, Butcher H, Lawton R. Comparison of radical mastectomy with alternative treatments for primary breast cancer. A first report of results from a prospective randomized clinical trial. Cancer. 1977 Jun;39(6 Suppl):2827-39. doi: 10.1002/1097-0142(197706)39:63.0.co;2-i. No abstract available.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Surgery, run by Institut Claudius Regaud 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 2 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: finished, as of the sponsor's last update on 11 Sep 2026. 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?
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?
Identification of the parameters associated with barriers to the evaluation of surgical innovations. (time frame: 21 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05865964, which also lists 33 linked publications.
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 11 Sep 2026.