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

NCT04200118 | Unknown

• 1 other identifier: 1901-BCN-011-MQ
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 2

Brief 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

Conditions

Male Infertility; Cancer; Epigenetic Disorder

Keywords

Sperm DNA fragmentation; Sperm epigenetics; Testicular cancer

Outcome Measures

Primary Outcomes (1)

• 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

Interventions

Observational OTHER

non intervention

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: male
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Sperm samples before treatment will be used as a control

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• IVI Barcelona: lead

Study Sites (2)

Ivi Barcelona

Barcelona, 08017, Spain

RECRUITING

IVI Barcelona

Barcelona, 08017, Spain

RECRUITING

MeSH Terms

Conditions

Infertility, Male; Neoplasms; Testicular Neoplasms

Interventions

Watchful Waiting

Condition Hierarchy (Ancestors)

Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Infertility; Male Urogenital Diseases; Endocrine Gland Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Urogenital Neoplasms; Endocrine System Diseases; Testicular Diseases; Gonadal Disorders

Intervention Hierarchy (Ancestors)

Outcome Assessment, Health Care; Outcome and Process Assessment, Health Care; Quality of Health Care; Health Services Administration

Central Study Contacts

Mariona Quera, MSc

CONTACT

34-932063000; mariona.quera@ivirma.com

Marga Esbert, PhD

CONTACT

34-932063000; marga.esbert@ivirma.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 4, 2019
• First Posted: December 16, 2019
• Study Start: November 29, 2019
• Primary Completion: April 1, 2020
• Study Completion: April 1, 2021
• Last Updated: December 16, 2019

Record last verified: 2019-07

Locations

ES (2)