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Could a simple blood test spare thyroid cancer patients from unnecessary radiation?

NCT ID NCT04290663

Disease control Sponsor: Centre Francois Baclesse Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study compares two approaches for treating intermediate-risk thyroid cancer after surgery. One group gets radioactive iodine as a standard precaution. The other group only gets it if a blood test and scan show signs of remaining cancer. The goal is to see if the selective approach works just as well while avoiding unnecessary treatment and side effects. About 368 patients will take part.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
radioactive iodine (I-131)
What this could lead to
If successful, this could spare many patients from unnecessary radioactive iodine treatment and its side effects, while still controlling the cancer effectively.
What could go wrong
This is a phase 3 trial, but it is still ongoing and results are not yet known. The guided approach might miss some cases that need treatment, or the two strategies could prove equally effective, meaning no change in practice.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 368 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2020

Expected to finish

Feb 2033

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Subgroup of patients with differentiated thyroid cancer and intermediate-risk defined as follows according to TNM 2017: * Papillary thyroid cancer (PTC) without aggressive subtype, follicular thyroid cancer (FTC) (with \< 4 foci of vascular invasion) or Hürthle cell carcinoma (HCC) * T1b or T2 with minimal extra-thyroid extension into the perithyroidal soft tissues and/or pN1 with largest nodal dimension between 2 and 10 mm, without extra-capsular invasion and with a number of metastatic nodes ≤ 10 * T1aN1 with largest nodal dimension between 2 and 10 mm, without extra-capsular invasion and with a number of metastatic nodes ≤ 10 * Patient treated by total thyroidectomy with macroscopically complete tumor resection (R0 or R1) ± neck dissection * Total thyroidectomy performed within 6 to 14 10 weeks before randomization * Patient with or without anti-thyroglobulin antibodies (TgAb) * No known distant metastases * Normal post-operative neck ultrasound (US) or if doubtful US, negative cytology and normal Tg value (\<10 ng/ml) in FNA washout fluid * Post-operative LT4 treatment initiated at least 6 weeks before randomization * Performance Status 0 or 1 * Patients aged 18 years or older * Signed informed consent form * Patient who agrees to be followed annually during 5 years * Patient affiliated to the French social security system Exclusion Criteria: * • Patients with: * medullary or anaplastic thyroid cancer * or poorly differentiated carcinoma * or well differentiated FTC with at least more than 4 foci of vascular invasion * or PTC with aggressive variants (tall cell or columnar cell carcinoma, diffuse sclerosing papillary, hobnail variant) * NIFTP (Noninvasive follicular thyroid neoplasm with papillary-like nuclear features) • Low-risk or high-risk DTC patients according to ATA 2015, and intermediate-risk patients with extra-thyroid extension into the perithyroidal muscles (pT3b according to pTNM 2017), and/or pN1 with nodal largest dimension \>10 mm or with extra-capsular invasion or more than 10 metastatic nodes. This excludes the following patients: * All pT1a, pT3 or pT4 * pT1aN0/x with or without minimal extra-thyroid extension * pT1bN0/x, pT2N0/Nx without minimal extra-thyroid extension * pT1aN1 or pT1bN1 or pT2N1 without extra-thyroid extension and with nodal largest dimension \<2mm * pT1aN1 or pT1bN1 or pT2N1 without extra-thyroid extension and with nodal largest dimension \>10mm * pT2N0/Nx without extra-thyroid extension * pT2N1 without extra-thyroid extension and with nodal largest dimension \<2mm * pT2N1 without extra-thyroid extension and with nodal largest dimension \>10mm * Surgery considered as macroscopically incomplete (R2) * Patients who have undergone lobectomy only * Post-operative neck US with metastatic lymph-nodes confirmed by cytology or by increased Tg (\>10 ng/ml) in FNA washout fluid * Drugs affecting thyroid function including iodinated contrast agents in the 6 weeks prior to randomization. Amiodarone should have been stopped at least 1 year before randomization. * Previous RAI treatment for thyroid cancer * Pregnant or lactating women * Any associated geographical, social or psychopathological condition that could compromise the patient's ability to participate in the study * Patient deprived of liberty or placed under the authority of a tutor * History of malignancy in the past 3 years, except skin cancer excluding melanoma, carcinoma in situ of the cervix. Any other solid tumor or lymphoma (without bone marrow involvement) must have been treated and not have shown signs of recurrence for at least 3 years

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Conditions

The condition(s) this trial relates to.

differentiated thyroid carcinoma thyroid cancer Thyroid Neoplasms

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Intermediate risk Thyroid cancer

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    29 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • AP-HP Pitié Salpétrière

    RECRUITING

    Paris, France

  • Bergonié

    RECRUITING

    Bordeaux, France

  • CHU Pointe à pitre

    NOT_YET_RECRUITING

    Pointe à Pitre, Guadeloupe, France

  • CHU TOULOUSE, Hôpital Larrey

    RECRUITING

    Toulouse, France

  • CHU Timone

    RECRUITING

    Marseille, France

  • Centre Antoine Lacassagne -

    RECRUITING

    Nice, France

  • Centre Francois Baclesse

    RECRUITING

    Caen, France

  • Centre Georges-François Leclerc

    RECRUITING

    Dijon, France

  • Centre Henri Becquerel

    RECRUITING

    Rouen, France

  • Centre Hospitalier Métropôle Savoie

    RECRUITING

    Chambéry, France

  • Centre Jean Godinot

    RECRUITING

    Reims, France

  • Centre Jean Perrin

    RECRUITING

    Clermont-Ferrand, France

  • Centre Léon Bérard

    RECRUITING

    Lyon, France

  • Centre Paul Strauss

    RECRUITING

    Strasbourg, France

  • Chru Lille

    RECRUITING

    Lille, France

  • Chu Angers

    RECRUITING

    Angers, France

  • Chu Brest

    RECRUITING

    Brest, France

  • Chu Grenoble

    RECRUITING

    Grenoble, France

  • Chu Martinique

    RECRUITING

    Fort de France, France

  • Chu Nancy

    RECRUITING

    Nancy, France

  • Chu Nantes

    RECRUITING

    Nantes, France

  • Chu Nimes

    RECRUITING

    Nîmes, France

  • Hospices Civils de Lyon

    RECRUITING

    Lyon, France

  • Hôpital saint-André

    RECRUITING

    Bordeaux, France

  • IUCT Oncopole

    RECRUITING

    Toulouse, France

  • Institu de Cancérologie de l'Ouest - Site Angers

    RECRUITING

    Angers, France

  • Institu de Cancérologie de l'Ouest - Site St Herblain

    RECRUITING

    Saint-Herblain, France

  • Institut CURIE, site Réné Huguenin

    RECRUITING

    Saint-Cloud, France

  • Institut Gustave Roussy

    RECRUITING

    Villejuif, France

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