An interventional study of biological sample and supraclavicular irradiation in Irradiation; Adverse Effect and Irradiation Hypothyroidism, sponsored by Institut Jean-Godinot. Completed at 3 sites in France. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-08-31.
Sponsored by Institut Jean-Godinot · Not applicable, Interventional, and Other
Prospective, multicentric, comparative, non randomised, in current care.
Primary objective:
Secondary objectives :
Prospective, multicentric, comparative, non randomised, in current care study
2 patient groups, non randomised, according to the necessity or not to perform a supra-clavicular irradiation:
Schedule
Projected inclusion duration of 18 months (duration to possibly adapt in order to obtain the number of required patients)
Intermediate study of the results in 30 months
Duration of follow-up of 60 months
217 studies on the registry are indexed under Hypothyroidism; 50 are open to participants now.
This study's enrollment of 500 is above the median of 70 across 109 interventional studies indexed under Hypothyroidism.
Browse Hypothyroidism studies →Institut Jean-Godinot is the lead sponsor of 9 studies on the registry; 4 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Adjuvant and neoadjuvant
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients received supraclavicular irradiation according to local policies. Biological samples were obtained in order to evaluate hypothyroidism during the follow-up period
Biological: biological sample · Radiation: supraclavicular irradiation
Patients did not receive supraclavicular irradiation according to local policies. Biological samples were obtained in order to evaluate hypothyroidism during the follow-up period
Biological: biological sample
T4, thyrotropic-stimulating hormone (TSH) and Thyroglobulin antibody were systematically measured
Irradiation of the homolateral supraclavicular area delivering 46 Gy in 23 fractions
Number of patients with treatment-related adverse effects on thyroid function as assessed by CTCAE v4.0
Time frame: Outcome measures will be assessed every 6 months up to 5 years.
Plan to share: Undecided
No publications or documents are linked to this record.
This study is completed, as verified in Aug 2021. You cannot join it, but the record below documents what was studied.
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Institut Jean-Godinot