MicroRNA as Markers in Testicular Cancer

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

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

Study Overview

• Status: Recruiting
• Conditions: Seminoma; Testicular Germ Cell Cancer; Non-Seminoma Testicular Cancer; Stage I Testicular Cancer; Stage II Testicular Cancer; Stage III Testicular Cancer; Stage IV Testicular Cancer; Relapse Testicular Cancer
• Intervention / Treatment: 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.

• Study Type: Observational
• Enrollment (Anticipated): 350

Contacts and Locations

• Study Contact: Name: Mette Pernille Myklebust, PhD; Phone Number: +47 41684492; Email: mette.pernille.myklebust@helse-bergen.no
• Study Contact Backup: Name: Olav Dahl, PhD; Phone Number: +47 55972081; Email: olav.dahl@helse-bergen.no

Study Locations

• Norway
  • Bergen, Norway, 5021
    • Recruiting
    • Haukeland University Hospital
    • Contact: Mette Pernille Myklebust, PhD; Phone Number: +47 41684492; Email: mette.pernille.myklebust@helse-bergen.no
  • Haugesund, Norway, 5528
    • Recruiting
    • Haugesund Hospital
    • Contact: Bogdan Stefan Bercea, MD; Phone Number: +47 52 73 20 00; Email: bogdan.stefan.bercea@helse-fonna.no
  • Oslo, Norway, 0379
    • Not yet recruiting
    • Oslo University Hospital
    • Contact: Helene Negaard, MD, PhD; Phone Number: +47 22 93 40 00; Email: UXHEGA@ous-hf.no
  • Tromsø, Norway, 9038
    • Recruiting
    • University Hospital of North Norway
    • Contact: Hege S. Haugnes, MD, PhD; Phone Number: +47 77 75 43 42; Email: hege.sagstuen.haugnes@unn.no
• Sweden
  • Göteborg, Sweden, 41345
    • Not yet recruiting
    • Sahlgrenska University Hospital
    • Contact: Anna G. Bergdahl, MD, PhD; Phone Number: +46 31 342 90 26; Email: anna.grenabo@vg.region.se
  • Stockholm, Sweden
    • Recruiting
    • Karolinska University Hospital
    • Contact: Anna Thor, MD; Email: anna.thor@ki.se
    • Contact: Anders Kjellman, MD, PhD; Phone Number: +46 073 699 52 58; Email: anders.kjellman@sll.se

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

• 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.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
miR371 as a biomarker in testicular germ cell cancer at orchiectomy	To estimate the sensitivity and specificity of miR371 in identifying viable tumour cells at diagnosis	5 years
miR371 as a biomarker in testicular germ cell cancer at RPLND	To estimate the sensitivity and specificity of miR371 in identifying viable tumour cells at RPLND	5 years
miR371 as a biomarker in testicular germ cell cancer during chemotherapy treatment	To estimate the performance of miR371 in monitoring of treatment efficiency (chemotherapy)	5 years
miR371 as a biomarker in testicular germ cell cancer and detection of recurrence	To estimate the performance of miR371 in (early) detection of recurrence	5 years

Collaborators and Investigators

• Sponsor: Haukeland University Hospital
• Collaborators: Karolinska University Hospital; Oslo University Hospital; University Hospital of North Norway; Sahlgrenska University Hospital, Sweden; Helse Fonna
• Investigators: Principal Investigator: Mette Pernille Myklebust, PhD, Haukeland University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 31, 2016
• Primary Completion (Anticipated): December 31, 2026
• Study Completion (Anticipated): December 31, 2026

Study Registration Dates

• First Submitted: May 31, 2021
• First Submitted That Met QC Criteria: June 3, 2021
• First Posted (Actual): June 4, 2021

Study Record Updates

• Last Update Posted (Actual): August 8, 2022
• Last Update Submitted That Met QC Criteria: August 5, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Endocrine System Diseases; Gonadal Disorders; Endocrine Gland Neoplasms; Genital Neoplasms, Male; Testicular Diseases; Germinoma; Neoplasms, Germ Cell and Embryonal; Testicular Neoplasms; Seminoma
• Other Study ID Numbers: 2015/1475

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No