Epigenetic and Genetic Effects in Cancer Patients: Analysis Pre and After Treatment
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04200118|
Recruitment Status : Unknown
Verified July 2019 by IVI Barcelona.
Recruitment status was: Recruiting
First Posted : December 16, 2019
Last Update Posted : December 16, 2019
The prognosis in cancer patients has improved over the years. Survivor rates have increased significantly, and paternity has become an important concern in more than 50% of young male survivors. Sperm cryopreservation before cancer treatment is highly recommendable in these patients, as a strategy to preserve their fertility due to is not possible to predict how the chemo or radiotherapy treatment will affect the spermatogenesis.
The objective of this study is to evaluate if sperm after an antineoplastic treatment can be safely used. To determine the possible effects of oncological treatments in the spermatogenesis, three parameters will be analyzed, aneuploidy frequencies, DNA fragmentation in single and double-strand breaks and methylation levels to determine epigenetic changes before and after the therapy.
If cancer treatment affect sperm genetic integrity, it would have a clinical impact in the offspring of these patients. Identify the different side effects of antineoplastic treatments in DNA sperm will provide a clinical improvement in order to select the best sperm sample in an IVF treatment and it will facilitate genetic counseling
|Condition or disease||Intervention/treatment|
|Male Infertility Cancer Epigenetic Disorder||Other: Observational|
|Study Type :||Observational|
|Estimated Enrollment :||30 participants|
|Official Title:||Epigenetic and Genetic Effects in Cancer Patients: Analysis Pre and After Treatment|
|Actual Study Start Date :||November 29, 2019|
|Estimated Primary Completion Date :||April 2020|
|Estimated Study Completion Date :||April 2021|
- Other: Observational
- Epigenetic profile of the patient [ Time Frame: 3 months ]The epigenetic analysis will be performed in the laboratories of the company "Sequentia Biotech". The treatment of denatured DNA with sodium bisulfite will be carried out, causing the demining of the cytosine not methylated, preserving the integrity of the Metilcitosines. After DNA sequencing, treated with bisulfite, the methylation state can be inferred directly from the readings aligned against a reference genome: an unmodified cytosine will indicate the existence of methylation in that position, while A thymine (result of PCR amplification after demining) will mean the existence of a non-methylated cytosine. The methylation values will be calculated with the MethylDackel software and the statistical analysis with R package bsseq.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04200118
|Contact: Mariona Quera, MScfirstname.lastname@example.org|
|Contact: Marga Esbert, PhDemail@example.com|
|Barcelona, Spain, 08017|
|Contact: Marga Esbert, PhD|
|Barcelona, Spain, 08017|
|Contact: Evelin L Molina 935 316 301 firstname.lastname@example.org|
|Principal Investigator: Agustín B Boluda|
|Sub-Investigator: Evelin L Molina|
|Sub-Investigator: Ana Belén C Balazote|
|Sub-Investigator: Verónica G Martínez|