ClinicalTrials.gg
Active, not recruitingNCT04435756Updated Mar 12, 2026

A Study of miRNA 371 in Patients With Germ Cell Tumors

An observational study in Germ Cell Tumor, Metachronous Malignant Neoplasm and Seminoma, sponsored by SWOG Cancer Research Network. Active, not recruiting at 424 sites in 3 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-03-12.

Primary conditionSeminomaRegistry: Neoplasms, Germ Cell and EmbryonalReclassifiedWhy we changed it
Registry
Neoplasms, Germ Cell and Embryonal — the first condition term the registry derived for this study.
ClinicalTrials.gg
Seminoma
Why
  1. The study's listed conditions name Seminoma, a narrower term within Neoplasms, Germ Cell and Embryonal.
Confidence
High: the new condition is named in the study's own listed conditions. Of 351 hand-checked studies reclassified this way, 68% were exactly right and 84% in the right disease family; the registry's first term was right for 5% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by SWOG Cancer Research Network · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
956
Ages
18 Years and older
Sex
All
01

Study summary

This trial studies whether the blood marker micro ribonucleic acid (miRNA) 371 can predict the chance of cancer returning in patients with germ cell cancers. Studying samples of blood from patients with germ cell cancers in the laboratory may help doctors predict how likely the cancer will come back.

Read the detailed description

PRIMARY OBJECTIVE:

I. To estimate the positive predictive value within each of the early stage testicular seminoma and nonseminoma groups using plasma miRNA 371 expression at relapse to detect germ cell malignancy.

SECONDARY OBJECTIVES:

I. To bank prospectively obtained serial liquid biospecimens for low and moderate risk of relapse patients annotated by patient level clinical data.

II. To bank prospectively collected, clinically annotated specimens for high risk patients and non-testicular primary patients in collaboration with Children's Oncology Group study AGCT 1531.

OUTLINE:

Patients undergo collection of blood every 3-6 months for up to 3 years.

02

Conditions studied

  • Germ Cell Tumor
  • Metachronous Malignant Neoplasm
  • Seminoma
  • Stage I Testicular Cancer AJCC v8
  • Stage IA Testicular Cancer AJCC v8
  • Stage IB Testicular Cancer AJCC v8
  • Stage IS Testicular Cancer AJCC v8

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03

In context

Seminoma Reclassified

63 studies on the registry are indexed under Seminoma; 15 are open to participants now.

Browse Seminoma studies →

Lead sponsor

SWOG Cancer Research Network is the lead sponsor of 339 studies on the registry; 37 are open to participants now.

Of its 17 completed or terminated interventional studies of FDA-regulated products, 17 (100%) have results posted.

Compared within Seminoma, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Neoplasms, Germ Cell and Embryonal. The counts are of registry records indexed under each term, refreshed daily. How we classify →

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Patients with newly diagnosed germ cell tumor

Eligibility criteria

Inclusion Criteria:

  • Patients must have a new diagnosis of a germ cell tumor. confirmed pathologically or serologically (diagnostic elevation of human chorionic gonadotropin [HCG]/alpha-fetoprotein [AFP]). All primary sites, stages, histological subtypes of germ cell tumor are eligible. Metachronous second primary germ cell tumors are eligible
  • If surgery is planned, male patients with clinical stage I testicular cancer must have orchiectomy completed within 42 days prior to registration
  • Patients must be registered within 42 days after diagnosis and prior to initiation of a management plan or treatment for the disease
  • Patients must have initial imaging, laboratory and other clinical evaluations (see below) performed within 42 days prior to registration. Imaging reports, pathology reports and performance status will be collected
  • Patients must have beta-human chorionic gonadotropin (beta- HCG), alpha-fetoprotein (AFP), and lactate dehydrogenase (LDH) assessments within 42 days prior to registration

    • NOTE: If the patient had an orchiectomy prior to registration, report tumor marker values before and after surgery on the Baseline Tumor Marker form
  • Patients must have risk of relapse assessment determined by the local investigator prior to registration
  • Patients must agree to submit required specimens for defined translational medicine studies. These specimens are drawn at the same time as standard laboratory evaluations (beta-HCG, AFP, and LDH); NOTE: Ideally, patients should be willing to return to their center performing surveillance (registering site) for the duration of the study to ensure that specimens are timed to standard clinical observations (the registering site's surveillance schedule)
  • Patients must be offered participation in specimen banking for future research. With patient's consent, specimens must be submitted.
  • Patients must be informed of the nature of this study and must sign and give written in accordance with institutional and federal guidelines
  • As a part of the Oncology Patient Enrollment Network (OPEN) registration process the treating institution's identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the system
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
956 participants (estimated)
Biospecimen retention
Samples with dna

Groups and cohorts

  • Observational (blood collection)

    Patients undergo collection of blood every 3-6 months for up to 3 years.

    Other: Biomarker Analysis · Procedure: Blood Product Collection

Interventions

  • OtherBiomarker Analysis

    Correlative study

  • ProcedureBlood Product Collection

    Undergo collection of blood

    Also known as: Collection, Blood Products

06

What researchers measure

Primary outcomes

  1. To estimate positive predictive value of miRNA 371 in early stage testicular seminoma and nonseminoma patients

    Positive predictive value will be estimated using plasma miRNA 371 expression at relapse.

    Time frame: Up to 3 years

  2. To bank blood specimens of patients at low risk and moderate risk of relapse

    10 ml whole blood will be collected at time points specified by the protocol.

    Time frame: Up to 3 years

07

Study locations

424 sites

Showing the first 100 of 424 sites across 3 countries. Choose a country and city above to see the rest.

08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Jul 2020 (actual). Primary completion is estimated for Jan 2027, 77 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 15, 2020
First posted
Jun 17, 2020
StartActual
Jul 28, 2020
Primary completionEst.
Jan 1, 2027
CompletionEst.
Jan 1, 2028
Last update
Mar 12, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 12, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04435756
Responsible party
Sponsor
First posted
Jun 17, 2020
Start date
Jul 28, 2020
Primary completion
Jan 1, 2027 (estimated)
Completion
Jan 1, 2028 (estimated)
Last update
Mar 12, 2026

Study contacts

Craig R Nichols
principal investigator · SWOG Cancer Research Network

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.

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