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

NCT ID: NCT04200118

Last Updated: 2019-12-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-11-29

Study Completion Date

2021-04-30

Brief Summary

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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

Detailed Description

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Conditions

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Male Infertility Cancer Epigenetic Disorder

Keywords

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Sperm DNA fragmentation Sperm epigenetics Testicular cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Observational

non intervention

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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IVI Barcelona

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Ivi Barcelona

Barcelona, , Spain

Site Status RECRUITING

IVI Barcelona

Barcelona, , Spain

Site Status RECRUITING

Countries

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Spain

Central Contacts

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Mariona Quera, MSc

Role: CONTACT

Phone: 34-932063000

Email: [email protected]

Marga Esbert, PhD

Role: CONTACT

Phone: 34-932063000

Email: [email protected]

Facility Contacts

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Marga Esbert, PhD

Role: primary

Evelin L Molina

Role: primary

Other Identifiers

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1901-BCN-011-MQ

Identifier Type: -

Identifier Source: org_study_id