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

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ClinicalTrials.gov Identifier: NCT04200118
Recruitment Status : Recruiting
First Posted : December 16, 2019
Last Update Posted : December 16, 2019
Sponsor:
Information provided by (Responsible Party):
IVI Barcelona

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


Condition or disease Intervention/treatment
Male Infertility Cancer Epigenetic Disorder Other: Observational

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Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Cohort
Time Perspective: Prospective
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



Intervention Details:
  • Other: Observational
    non intervention


Primary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Sampling Method:   Probability Sample
Study Population
Sperm samples before treatment will be used as a control
Criteria

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


Information from the National Library of Medicine

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


Contacts
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Contact: Mariona Quera, MSc 34-932063000 mariona.quera@ivirma.com
Contact: Marga Esbert, PhD 34-932063000 marga.esbert@ivirma.com

Locations
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Spain
Ivi Barcelona Recruiting
Barcelona, Spain, 08017
Contact: Marga Esbert, PhD         
IVI Barcelona Recruiting
Barcelona, Spain, 08017
Contact: Evelin L Molina    935 316 301    evelin.lara@ivi.es   
Principal Investigator: Agustín B Boluda         
Sub-Investigator: Evelin L Molina         
Sub-Investigator: Ana Belén C Balazote         
Sub-Investigator: Verónica G Martínez         
Sponsors and Collaborators
IVI Barcelona
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Responsible Party: IVI Barcelona
ClinicalTrials.gov Identifier: NCT04200118    
Other Study ID Numbers: 1901-BCN-011-MQ
First Posted: December 16, 2019    Key Record Dates
Last Update Posted: December 16, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by IVI Barcelona:
Sperm DNA fragmentation
Sperm epigenetics
Testicular cancer
Additional relevant MeSH terms:
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Infertility
Infertility, Male