Epigenetic and Genetic Effects in Cancer Patients: Analysis Pre and After Treatment

Cancer Clinical Trial

Official title:

Epigenetic and Genetic Effects in Cancer Patients: Analysis Pre and After Treatment

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04200118
• Other study ID #: 1901-BCN-011-MQ
• Status: Recruiting
• Start date: November 29, 2019
• Est. completion date: April 2021

Study information

• Verified date: July 2019
• Source: IVI Barcelona
• Contact: Mariona Quera, MSc
• Phone: 34-932063000
• Email: mariona.quera[@]ivirma.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: April 2021
• Est. primary completion date: April 2020
• Gender: Male
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

Patients with previous history of cancer Patients with several sperm samples cryopreserved to be able to thaw a part without damaging their future options, in case they need them.

Patients treated with chemotherapy and/or radiotherapy Patients have finished their oncological treatment. Patints recovered spermatogenesis after the oncological treatment to be able to obtain a sperm sample.

Exclusion Criteria:

Patients with only one sperm sample cryopreserved Patients that are not be able to obtain a fresh sample post treatment Patients with less than 3 million sperm per milliliter

Related Conditions & MeSH terms

• Cancer
• Epigenetic Disorder
• Infertility
• Infertility, Male
• Male Infertility

Intervention

Other:
• Observational
non intervention

Locations

Country	Name	City	State
Spain	Ivi Barcelona	Barcelona
Spain	IVI Barcelona	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
IVI Barcelona

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Epigenetic profile of the patient	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.	3 months