Actively Recruiting

Age: 18Years - 70Years
MALE
ID04914026

MicroRNA-371 as Markers for Disease Activity and Monitoring Chemotherapy and Recurrence in Testicular Germ Cell Tumors

Led by Haukeland University Hospital · Updated on 2022-08-08

350

Participants Needed

6

Research Sites

N/A

Total Duration

On this page

Sponsors

H

Haukeland University Hospital

Lead Sponsor

K

Karolinska University Hospital

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are evaluating the use of microRNA-371a-5p (miR371) as a marker to manage testicular germ cell cancer. The study aims to determine how well miR371 detects active tumor cells during orchiectomy, treatment, surveillance, and in the early detection of cancer recurrence. This observational study focuses on improving monitoring methods for patients with different stages of testicular cancer. Participants will have blood samples collected at diagnosis, during treatment, during surveillance, and every 3 to 6 months to analyze miR371 levels. The study tracks the biomarker's performance at key points such as orchiectomy, retroperitoneal lymph node dissection (RPLND), chemotherapy, and recurrence detection over a 5-year period. During the study, participants will undergo regular blood draws to monitor miR371 as a biomarker. Researchers will assess how well miR371 corresponds to disease activity and treatment effects. The study provides long-term follow-up to observe biomarker changes and detect possible recurrence, helping guide future care strategies for testicular germ cell cancer patients.

CONDITIONS

Brief Title

MicroRNA as Markers in Testicular Cancer

Who Can Participate

Age: 18Years - 70Years
MALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients with suspected testicular cancer referred to orchiectomy
  • Patients diagnosed with testicular germ cell cancer
  • Age 18 to 70 years
  • Able to receive information and provide consent
Not Eligible

You will not qualify if you...

  • History of other prior or current cancers besides testicular cancer
  • Any disease or condition that prevents receiving information or participating in follow-up

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - At diagnosis

Blood samples are collected at diagnosis to assess the presence of microRNA-371a-5p (miR371) as a biomarker for testicular germ cell tumors.

1 visit (in-person)

Treatment Monitoring

Duration - During chemotherapy treatment

Blood samples are collected during chemotherapy treatment to monitor miR371 levels and disease activity.

Visits as per treatment schedule

Surveillance

Duration - Up to 5 years

Participants are monitored through blood sample collection every 3 to 6 months to detect recurrence and assess disease activity post-treatment.

Blood collection every 3 to 6 months

Trial Site Locations

Total: 6 locations

1

Haukeland University Hospital

Bergen, Norway, 5021

Actively Recruiting

2

Haugesund Hospital

Haugesund, Norway, 5528

Actively Recruiting

3

Oslo University Hospital

Oslo, Norway, 0379

Not Yet Recruiting

4

University Hospital of North Norway

Tromsø, Norway, 9038

Actively Recruiting

5

Sahlgrenska University Hospital

Gothenburg, Sweden, 41345

Not Yet Recruiting

6

Karolinska University Hospital

Stockholm, Sweden

Actively Recruiting

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Research Team

M

Mette Pernille Myklebust, PhD

O

Olav Dahl, PhD

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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