Clinical trial · Interventional
Testicular Function After Iodine 131 Therapy in Papillary Carcinoma Patients
Study of the Testicular Function After Iodine 131 Therapy in Patients With Papillary Carcinoma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Papillary cancer may affect patients of any age,with a good prognosis. Most of young patients may hence procreate as often as the general population.131iodine is an essential tool during treatment of thyroid cancer. According literature data, 131iodine given patients may experience exocrine testicular dysfunction with transient azoospermia, as a significant growing number of Desoxyribonucleic acid (DNA) damage may concern the patient or his offspring. The primary purpose will be to study a genomic instability within the germinal line, based on a significant mutation rate analysis in their minisatellites regions after 100 mCi 131 iodine irradiation compared to the baseline spermogram of each patient, thus being his own control case in a cross-over study.The inclusion of 50 patients treated by surgery prior to131iodine would result in statistically significant results.This multicentric cross-over study with a multidisciplinary approach will act for a direct benefit on testis function in patients aged 18-45 treated by 131iodine for thyroid cancer. Samples measurements timing will be: after surgery, 2 and 12 months after 131iodine administration.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Thyroid Neoplasms | Thyroid Gland Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Administration of 131 iodine | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 1
- description
- Patients treated by 131 iodine for thyroid cancer
- interventionNames
- Drug: Administration of 131 iodine
Primary outcomes (1)
- measure
- A genomic instability within the germinal line
- timeFrame
- 12 months after iodine131 administration
- description
- To study a genomic instability within the germinal line, based on a significant mutation rate analysis in their minisatellite regions after 100 mCi 131 iodine irradiation compared to the baseline spermogram of each patient, thus being his own control case in a cross-over study
Secondary outcomes (7)
- measure
- The spermatozoid apoptosis and aneuploidy levels
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
- Maximum age
- 55 Years
Show eligibility criteria text
Inclusion Criteria: * Men from 18 to 55 years treated by thyroid surgery for papillary carcinoma followed by iodine 131 radiotherapy * informed consent Exclusion Criteria: * The patients under supervision (guardianship), under guardianship. * Patients of less than 18 years old and furthermore of 55 years old * Hypogonadism known or bare during the hormonal balance sheet of inclusion. * The patients with a history of definitive azoospermia· * Azoospermia at baseline spermogram * Chemotherapy or radiotherapy history * The patients exposed to toxic substance for the spermatogenesis
References
Publications (1)
- DERIVEDBourcigaux N, Rubino C, Berthaud I, Toubert ME, Donadille B, Leenhardt L, Petrot-Keller I, Brailly-Tabard S, Fromigue J, de Vathaire F, Simon T, Siffroi JP, Schlumberger M, Bouchard P, Christin-Maitre S. Impact on testicular function of a single ablative activity of 3.7 GBq radioactive iodine for differentiated thyroid carcinoma. Hum Reprod. 2018 Aug 1;33(8):1408-1416. doi: 10.1093/humrep/dey222. PMID 29912343