Testicular Function After Iodine 131 Therapy in Papillary Carcinoma Patients

NCT01150318 | Completed

• 1 other identifier: P040419
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

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

Thyroid Neoplasms

Keywords

Male; Infertility; Radioisotopes Therapy; Follicular thyroid cancer

Outcome Measures

Primary Outcomes (1)

• A genomic instability within the germinal line

  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

  12 months after iodine131 administration

Secondary Outcomes (7)

• The spermatozoid apoptosis and aneuploidy levels

  1 month before iodine131 administration

• The exocrine and endocrine testicular function

  1 month before iodine131 administration

• The radiation doses delivered to the testis in exposed patients

  72 hours after 131 iodine administration

• The exocrine and endocrine testicular function

  3 months after iodine131 administration

• The exocrine and endocrine testicular function

  12 months after iodine131 administration

Study Arms (1)

1

EXPERIMENTAL

Patients treated by 131 iodine for thyroid cancer

Drug: Administration of 131 iodine

Interventions

Administration of 131 iodine DRUG

100 mCi 131 iodine irradiation

Also known as: 131 iodine

1

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Men from 18 to 55 years treated by thyroid surgery for papillary carcinoma followed by iodine 131 radiotherapy
• informed consent

You may not qualify if:

• The patients under supervision (guardianship), under guardianship.
• Patients of less than 18 years old and furthermore of 55 years old
• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Saint Antoine Hospital, Endocrinology Unit

Paris, 75012, France

Location

Related Publications (1)

• Bourcigaux 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 DERIVED

MeSH Terms

Conditions

Thyroid Neoplasms; Infertility; Adenocarcinoma, Follicular

Interventions

Iodine-131

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Endocrine System Diseases; Thyroid Diseases; Genital Diseases; Urogenital Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Study Officials

• Philippe Bouchard, MD, PhD

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 29, 2010
• First Posted: June 24, 2010
• Study Start: January 1, 2006
• Primary Completion: June 1, 2010
• Study Completion: June 1, 2010
• Last Updated: August 7, 2013

Record last verified: 2013-08

Locations

FR (1)