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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

Tracking Information
First Submitted Date May 31, 2021
First Posted Date June 4, 2021
Last Update Posted Date June 4, 2021
Actual Study Start Date December 31, 2016
Estimated Primary Completion Date December 31, 2026   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 3, 2021)
  • 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
  • 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
  • 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)
  • 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
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title MicroRNA as Markers in Testicular Cancer
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
Brief Summary The main objective of this study is establish the performance of miR371 in management of testicular cancer
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.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Blood is collected in order to extract RNA.
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.
Condition
  • 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
Intervention Other: Biomarker analysis
Blood collection. Blood samples will be collected at diagnosis, during surveillance, during treatment and every 3-6 months
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: June 3, 2021)
350
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 31, 2026
Estimated Primary Completion Date December 31, 2026   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: Male
Gender Based Eligibility: Yes
Gender Eligibility Description: Testicular Germ Cell Cancer
Ages 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Mette Pernille Myklebust, PhD +47 41684492 mette.pernille.myklebust@helse-bergen.no
Contact: Olav Dahl, PhD +47 55972081 olav.dahl@helse-bergen.no
Listed Location Countries Norway,   Sweden
Removed Location Countries  
 
Administrative Information
NCT Number NCT04914026
Other Study ID Numbers 2015/1475
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Haukeland University Hospital
Study Sponsor Haukeland University Hospital
Collaborators
  • Karolinska University Hospital
  • Sahlgrenska University Hospital, Sweden
  • Helse Fonna
  • University Hospital of North Norway
  • Oslo University Hospital
Investigators
Principal Investigator: Mette Pernille Myklebust, PhD Haukeland University Hospital
PRS Account Haukeland University Hospital
Verification Date May 2021