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MicroRNA as Markers in Testicular Cancer

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ClinicalTrials.gov Identifier: NCT04914026
Recruitment Status : Recruiting
First Posted : June 4, 2021
Last Update Posted : June 4, 2021
Sponsor:
Collaborators:
Karolinska University Hospital
Sahlgrenska University Hospital, Sweden
Helse Fonna
University Hospital of North Norway
Oslo University Hospital
Information provided by (Responsible Party):
Haukeland University Hospital

Brief Summary:
The main objective of this study is establish the performance of miR371 in management of testicular cancer

Condition or disease Intervention/treatment
Testicular Germ Cell Cancer Seminoma Non-Seminoma Testicular Cancer Stage I Testicular Cancer Stage II Testicular Cancer Stage III Testicular Cancer Stage IV Testicular Cancer Relapse Testicular Cancer Other: Biomarker analysis

Detailed Description:
The main objective of the study is to asses the sensitivity and specificity of microRNA-371a-5p (miR371) in detection of viable testicular germ tumour cells. To assess the utility of miR371 at orchiectomy, during treatment and surveillance and in early detection of recurrence.

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Study Type : Observational
Estimated Enrollment : 350 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: MicroRNA-371 as Markers for Disease Activity and as a Tool to Monitor the Effect of Chemotherapy and Early Detection of Recurrence in Patients With Testicular Germ Cell Tumours
Actual Study Start Date : December 31, 2016
Estimated Primary Completion Date : December 31, 2026
Estimated Study Completion Date : December 31, 2026

Resource links provided by the National Library of Medicine



Intervention Details:
  • Other: Biomarker analysis
    Blood collection. Blood samples will be collected at diagnosis, during surveillance, during treatment and every 3-6 months


Primary Outcome Measures :
  1. miR371 as a biomarker in testicular germ cell cancer at orchiectomy [ Time Frame: 5 years ]
    To estimate the sensitivity and specificity of miR371 in identifying viable tumour cells at diagnosis

  2. miR371 as a biomarker in testicular germ cell cancer at RPLND [ Time Frame: 5 years ]
    To estimate the sensitivity and specificity of miR371 in identifying viable tumour cells at RPLND

  3. miR371 as a biomarker in testicular germ cell cancer during chemotherapy treatment [ Time Frame: 5 years ]
    To estimate the performance of miR371 in monitoring of treatment efficiency (chemotherapy)

  4. miR371 as a biomarker in testicular germ cell cancer and detection of recurrence [ Time Frame: 5 years ]
    To estimate the performance of miR371 in (early) detection of recurrence


Biospecimen Retention:   Samples With DNA
Blood is collected in order to extract RNA.


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Testicular Germ Cell Cancer
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Men with suspected and confirmed testicular germ cell cancer, aged 18-70 years. Seminomas and non-seminomas, stage I-IV.
Criteria

Inclusion Criteria:

  • Patients with suspected testicular cancer, referred to orchiectomy.
  • Patients diagnosed with testicular germ cell cancer.
  • Age 18-70 years of age.
  • Must be able receive information and to consent.

Exclusion Criteria:

  • Other prior or concomitant malignancy (other than testicular cancer).
  • Other diseases or conditions that hinder the ability to receive information and to participate in follow-up procedures.

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): NCT04914026


Contacts
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Contact: Mette Pernille Myklebust, PhD +47 41684492 mette.pernille.myklebust@helse-bergen.no
Contact: Olav Dahl, PhD +47 55972081 olav.dahl@helse-bergen.no

Locations
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Norway
Haukeland University Hospital Recruiting
Bergen, Norway, 5021
Contact: Mette Pernille Myklebust, PhD    +47 41684492    mette.pernille.myklebust@helse-bergen.no   
Haugesund Hospital Recruiting
Haugesund, Norway, 5528
Contact: Bogdan Stefan Bercea, MD    +47 52 73 20 00    bogdan.stefan.bercea@helse-fonna.no   
Oslo University Hospital Not yet recruiting
Oslo, Norway, 0379
Contact: Helene Negaard, MD, PhD    +47 22 93 40 00    UXHEGA@ous-hf.no   
University Hospital of North Norway Recruiting
Tromsø, Norway, 9038
Contact: Hege S. Haugnes, MD, PhD    +47 77 75 43 42    hege.sagstuen.haugnes@unn.no   
Sweden
Sahlgrenska University Hospital Not yet recruiting
Göteborg, Sweden, 41345
Contact: Anna G. Bergdahl, MD, PhD    +46 31 342 90 26    anna.grenabo@vg.region.se   
Karolinska University Hospital Recruiting
Stockholm, Sweden
Contact: Anna Thor, MD       anna.thor@ki.se   
Contact: Anders Kjellman, MD, PhD    +46 073 699 52 58    anders.kjellman@sll.se   
Sponsors and Collaborators
Haukeland University Hospital
Karolinska University Hospital
Sahlgrenska University Hospital, Sweden
Helse Fonna
University Hospital of North Norway
Oslo University Hospital
Investigators
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Principal Investigator: Mette Pernille Myklebust, PhD Haukeland University Hospital
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Responsible Party: Haukeland University Hospital
ClinicalTrials.gov Identifier: NCT04914026    
Other Study ID Numbers: 2015/1475
First Posted: June 4, 2021    Key Record Dates
Last Update Posted: June 4, 2021
Last Verified: May 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Seminoma
Testicular Neoplasms
Neoplasms, Germ Cell and Embryonal
Germinoma
Neoplasms by Histologic Type
Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Genital Neoplasms, Male
Urogenital Neoplasms
Endocrine System Diseases
Testicular Diseases
Gonadal Disorders