Advertisement

Topics

Testicular Function After Iodine 131 Therapy in Papillary Carcinoma Patients

2014-08-27 03:12:42 | BioPortfolio

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.

Description

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, concerning ablation of the orthotopic thyroid remnant and/or distant metastasis. According literature data, 131iodine given patients may experience exocrine testicular dysfunction with transient azoospermia, as a significant growing number of DNA damage may concern the patient or his offspring. No higher malformation risk has been described in children fathered by patients who has received 131iodine for thyroid cancer. But animal studies showed a genomic instability leading to a major cancer risk in the offspring of male mice receiving isotopic radiotherapy. The deduced hypothesis is that a genetic toxicity of those radiation exists on the germ cells, and most of all that those acquired mutations may be transmitted to the next generation, majoring a risk of somatic mutation accumulation. So is described TCHERNOBYL exposed patients and their children. Unfortunately, little is known on trans-generational genomic instability.

The primary outcome will be 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. Literature reports a risk ratio rising from 1,4 to 1,6 for a comparable exposition dose. Under a 2,5 % spontaneous mutation rate hypothesis and for 1000 minisatellites studied per subject, with the mutation rate rising to 50% (RR=1,5), as the inter-individual variability is expected to be high : the inclusion of 50 patients treated by surgery prior to131iodine would result in statistically significant results.

Secondary outcomes will be to look for deleterious endpoints on spermatogenesis, such as : apparition of a low number of spermatozoids, a low vitality, a low mobility, elevated apoptosis and aneuploidy rate found in sperm of treated subjects vs before iodine treatment. Therefore, the kinetics of spermogram parameters alteration will be available. Testosterone/LH ratio will be assessed before and after 131iodine. Direct measure of testis irradiation obtained by a scrotal dosimeter will permit calculation of the delivered irradiation dose and a dose/effect relation between the different parameters.

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. Therefore, endpoints such as medical examination, exocrine and endocrine testis function in blood and spem sampling will be assessed in order to obtain spermogram, Sperm Cytogram, aneuploidy/apoptosis, minisatellites region mutation rate. Medical examination will take place in each local site, either from endocrinology, oncology, nuclear medicine departments. The sperm samples and spermogram, Sperm Cytogram, irradiation- induced abnormalises studies will be centralized at the CECOS (Tenon Hospital, Paris, France). Hormonal dosages will be processed in Bicêtre Hospital (Kremlin-Bicêtre, France). Minisatellites mutations study processed on frozen sperm samples will take place in the Genetic of Radiosensibility Department (Commissionership in the energy atomic, SACLAY, France).

This study would permit to measure out the minisatellites region mutation rate frequency, aneuploidy and DNA damage frequency, and finally kinetics of those alterations after 131iodine irradiation for human thyroid cancer. At the clinical level, practitioners would more precisely advise their patients on potential fertility risks and help to choose the appropriate practice in order to preserve it before thyroid cancer treatment. Knowing those results, it may redefine iodine indication. The knowledge of irradiation-induced genomic abnormalises is critical, regarding the growing number of examinations (Computed Tomography or Positron Emission Tomography-scans), known to deliver the same amount of irradiation.

Study Design

Allocation: Non-Randomized, Control: Uncontrolled, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Thyroid Neoplasms

Intervention

Administration of 131 iodine

Location

Saint Antoine Hospital, Endocrinology Unit
Paris
France
75012

Status

Active, not recruiting

Source

Assistance Publique - Hôpitaux de Paris

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:12:42-0400

Clinical Trials [599 Associated Clinical Trials listed on BioPortfolio]

Minimize Radioactive Iodine Ablation Of Remnant Thyroid in Differentiated Thyroid Cancer

The researchers investigated the rate of biochemical remission in patients without radioactive iodine therapy compared to patients with low dose radioactive iodine treatment in differentia...

Reacquisition of Radioactive Iodine (RAI) Uptake of RAI-Refractory Metastatic Thyroid Cancers by Pretreatment With the Selective MEK Inhibitor AZD6244

The purpose of this study is to find out if the drug AZD6244 can improve the radioactive iodine uptake by the patient's metastatic thyroid cancer. The investigator will also be testing the...

Iodine I 131 With or Without Thyroid-Stimulating Hormone in Treating Patients Who Have Undergone Surgery for Thyroid Cancer

RATIONALE: Radioactive iodine uses radiation to kill tumor cells. Giving iodine I 131 with or without thyroid-stimulating hormone after surgery may kill any tumor cells that remain after s...

Iodine I 131 in Treating Patients With Thyroid Cancer

RATIONALE: Radioactive iodine kills thyroid cancer cells by giving off radiation. PURPOSE: This clinical trial is studying the side effects, best dose, and how well iodine I 131 works in ...

Azacitidine to Restore Thyroid Function in Patients With Persistent or Metastatic Thyroid Cancer

RATIONALE: Azacitidine may help thyroid cancer cells regain the ability to take up iodine. This would allow the cancer to be detected and treated by radioactive iodine. PURPOSE: Phase I t...

PubMed Articles [5040 Associated PubMed Articles listed on BioPortfolio]

Optimal KI Prophylactic Dose Determination for Thyroid Radiation Protection After a Single Administration in Adult Rats.

A dose-response study was performed in adult rats to select an optimal stable potassium iodide (KI) dose which could be implemented in repeated prophylaxis, in case of prolonged exposure to radioactiv...

Iodine and Thyroid Function Status, and Anti-thyroid Peroxidase Antibody among Pregnant Women in Eastern Nepal.

Iodine deficiency, thyroid dysfunction and development of thyroid autoimmunity during pregnancy may affect mother and the developing fetus. This study was carried out to find iodine status, thyroid dy...

Iodine Symporter Targeting with (124)I/(131)I Theranostics.

Theranostics, a modern approach combining therapeutics and diagnostics, is among the most promising concepts in nuclear medicine for optimizing and individualizing treatments for many cancer entities....

Breast-Milk Iodine Concentrations and Iodine Levels of Infants According to the Iodine Status of the Country of Residence: A Systematic Review and Meta-Analysis.

Iodine, an essential micronutrient, plays a critical role in normal growth and development, especially during the first two years of life. This systematic review and meta-analysis is among the first t...

Optimal iodine supplementation during anti-thyroid drug therapy for Graves' disease is associated with lower recurrence rates than iodine restriction.

A relationship between iodine intake and the effectiveness of anti-thyroid drug (ATD) therapy for Graves' disease (GD) has been suggested and strict restriction of iodine intake has been tried in the ...

Medical and Biotech [MESH] Definitions

An aggressive THYROID GLAND malignancy which generally occurs in IODINE-deficient areas in people with previous thyroid pathology such as GOITER. It is associated with CELL DEDIFFERENTIATION of THYROID CARCINOMA (e.g., FOLLICULAR THYROID CARCINOMA; PAPILLARY THYROID CANCER). Typical initial presentation is a rapidly growing neck mass which upon metastasis is associated with DYSPHAGIA; NECK PAIN; bone pain; DYSPNEA; and NEUROLOGIC DEFICITS.

A form of IODINE deficiency disorders characterized by an enlargement of the THYROID GLAND in a significantly large fraction of a POPULATION GROUP. Endemic goiter is common in mountainous and iodine-deficient areas of the world where the DIET contains insufficient amount of iodine.

A dehydrated extract of thyroid glands from domesticated animals. After the removal of fat and connective tissue, the extract is dried or lyophilized to yield a yellowish to buff-colored amorphous powder containing 0.17-0.23% of iodine.

A dehydrated extract of thyroid glands. After the removal of fat and connective tissue, the extract is dried or lyophilized to yield a yellowish to buff-colored amorphous powder containing 0.17-0.23% of iodine.

Use of radiolabeled antibodies for diagnostic imaging of neoplasms. Antitumor antibodies are labeled with diverse radionuclides including iodine-131, iodine-123, indium-111, or technetium-99m and injected into the patient. Images are obtained by a scintillation camera.

More From BioPortfolio on "Testicular Function After Iodine 131 Therapy in Papillary Carcinoma Patients"

Advertisement
Quick Search
Advertisement
Advertisement

 

Relevant Topics

Head and neck cancers
Cancer can occur in any of the tissues or organs in the head and neck. There are over 30 different places that cancer can develop in the head and neck area. Mouth cancers (oral cancers)  - Mouth cancer can develop on the lip, the tongue, the floor...

Thyroid Disorders
The thyroid is a butterfly-shaped gland in the neck, just above thecollarbone and is an endocrine gland that make hormones. These Thyroid hormones control the rate of many activities in the body, including how fast the body burns calories and how fast th...

Pancreatitis
Pancreatitis Acute pancreatitis is inflammation of the pancreas caused by the release of activated pancreatic enzymes. Common triggers are biliary tract disease and chronic heavy alcohol intake.  Diagnosis is based on clinical presentation...


Searches Linking to this Trial