EDC for thyroid cancer clinical trials
Thyroid cancer is several diseases. Low-risk differentiated cancer trials ask how little treatment is enough; radioiodine-refractory and anaplastic trials ask about progression and survival on targeted drugs; medullary trials follow calcitonin. Build the design you actually have in Capture and test it free.
- Thyroglobulin and TSH series
- Radioiodine activity and dates
- Target-drug toxicity and dose changes
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| Low-risk differentiated | RAI-refractory differentiated | Medullary / anaplastic | |
|---|---|---|---|
| Typical question | Is less treatment non-inferior? | Does the drug delay progression? | Response and survival |
| Core endpoint data | Recurrence, biochemical response | Imaging-based progression | Imaging, markers, survival |
| Biomarker series | Thyroglobulin, antibodies, TSH | Thyroglobulin as supportive | Calcitonin, CEA (medullary) |
| Toxicity weight | Low | High (dose modification) | High |
| Follow-up length | Years | Until progression | Until progression or death |
What a thyroid cancer trial needs from its EDC
- A histology-specific model: papillary and follicular (differentiated), medullary and anaplastic cancers have different endpoints, markers and toxicities, so one generic oncology template will not serve.
- Imaging endpoints with an outside reader: registered randomised trials in radioiodine-refractory disease have used progression-free survival and response rate by RECIST 1.1 reviewed by a blinded independent committee. The EDC holds tumour assessment data and dates; the reading and committee sit outside it.
- Biochemical series: thyroglobulin with antibody status and TSH, and calcitonin and CEA in medullary disease, over many time points with units and assay noted.
- Radioiodine records: administered activity, preparation method, dates and uptake findings are protocol data.
- Targeted-drug toxicity: dose interruptions, reductions, blood pressure, hand-foot skin reaction, QTc and calcium or parathyroid issues after surgery need a structured, graded record.
The endpoint model
Progression-free survival, biochemical response and de-escalation
The pivotal randomised trials in radioiodine-refractory differentiated thyroid cancer are the clearest template for the oncology end of this page. The sorafenib DECISION trial used progression-free survival by RECIST as its primary endpoint. The later COSMIC-311 trial of cabozantinib, in patients who had progressed on a VEGFR-targeted therapy, named progression-free survival and objective response rate, both by RECIST 1.1 assessed by a blinded independent radiology committee, as co-primary endpoints. These are published examples of shape, not recommendations: your design may be single-arm, phase 1 dose finding, or neoadjuvant.
At the other end are de-escalation questions in low-risk disease: whether surgery can be less extensive, whether postoperative radioiodine is needed, whether active surveillance is safe for small tumours. These trials care less about progression and more about recurrence, biochemical and structural response and quality of life, over many years. Response categories are usually described with an American Thyroid Association style scheme (excellent, indeterminate, biochemical incomplete, structural incomplete), built from thyroglobulin, antibodies and imaging at set times. The exact thresholds depend on the assay and guideline version, so write the rule in the protocol and let an edit check flag a missing antibody result next to a thyroglobulin value, because antibodies can distort the measurement.
Staging is another trap. The AJCC staging edition and the risk stratification used (for example ATA initial risk) change over time, so record the version used for each participant and keep the fields locked after approval. Capture stores what you enter and a full audit trail; it does not stage the tumour or measure lesions, and it has no imaging or RECIST tools, so tumour measurements come from your imaging reader or sponsor charter and are entered as lesion records with dates.
Thyroid markers
Thyroglobulin
TGAnti-thyroglobulin antibodies
TGABTSH
TSHWithin the suppression target set in the protocol
Assay and units recorded
TGASSAYCalcium
CABelow the lab reference range: confirm and record on the adverse event form if needed
Protocol to build
Thyroid cancer protocol elements and where they live in Capture
| Protocol element | What the data looks like | Where it lives in Capture |
|---|---|---|
| Diagnosis and staging | Histology, subtype, molecular findings, staging edition, initial risk group | Screening and baseline forms; version fields locked after approval |
| Surgery and pathology | Extent of surgery, margins, lymph node findings, post-operative calcium and PTH | Surgical history form; medical history |
| Radioiodine treatment | Administered activity, date, preparation, post-therapy scan result | Treatment form with date fields; repeating rows for repeat courses |
| Thyroid markers | Thyroglobulin, antibodies, TSH, calcitonin, CEA with assay and units | Thyroid panel template; lab ranges |
| Tumour assessment | Target and non-target lesions, sum of diameters, response category, scan date | Repeating-row lesion form; reading stays with the imaging reader |
| Performance status | ECOG at each visit | ECOG performance status form |
| Toxicity | CTCAE grade, dose modification, action taken | Adverse event form and CTCAE grade lookup |
| Cardiac safety | ECG, QTc, medication that prolongs QT | QTc calculator; QTc Bazett and Fridericia available as calculated fields |
Capture does not read images, measure lesions or connect to central imaging or laboratory vendors. Exports are provided for those partners.
Build the marker series and toxicity log before first patient
Create the thyroglobulin, calcium and tumour assessment forms, then test grading and dose-modification entries in the sandbox. Free, no credit card.
Operations
Dose modifications, long follow-up and rare-disease sites
Targeted-drug trials generate dense dose-change data. A participant on a multikinase inhibitor may have the dose interrupted for hypertension, reduced for hand-foot skin reaction, and re-escalated, all with dates. Record each change as a repeating row with the dose, the reason, the related adverse event and the date, so exposure can be reconstructed. Registered thyroid-cancer trials also follow blood pressure, proteinuria, liver tests and electrocardiograms, depending on the drug, so your protocol's monitoring list becomes forms and checks. Hypocalcaemia and hypoparathyroidism after total thyroidectomy are an additional toxicity class not seen in many solid tumour trials.
Follow-up in differentiated cancer is long because the disease is slow. A participant in a de-escalation trial may be followed for five or ten years, with annual biochemical checks and ultrasound. A study of that length needs a data-retention plan and a way to keep contact details current. Capture's audit trail and soft-delete behaviour support retention, and CSV or Excel exports with a data dictionary and SDTM export (SAS XPT with Define-XML) support later analysis. See clinical trial data archiving and retention.
Many thyroid cancer subtypes are rare. Medullary and anaplastic disease trials often recruit across a handful of specialist centres. Site-level participant numbering and by-site filtering help a coordinating team compare centres, and QR-code enrolment can onboard participants at a site without an app install. For broader oncology design questions, such as RECIST and safety reporting structure, see EDC for oncology clinical trials; for the hormonal side of thyroid disease generally, see EDC for endocrinology trials. Patient-reported symptom diaries during treatment are covered in oncology side-effect diary ePRO.
Before first participant
Thyroid cancer study readiness checklist
Histology and staging versions fixed
Staging edition and risk scheme named in the protocol and on the form.
Marker assays defined
Assay, units and antibody handling agreed with the lab and statistician.
Response rules written
Biochemical and structural response definitions with time points.
Imaging workflow documented
Who reads scans, where lesion data are entered, and how the independent review receives them.
Dose-modification log tested
Repeating rows linked to adverse events.
Retention plan agreed
Contact updates and archive plan for multi-year follow-up.
Can Capture handle RECIST measurements?
It stores lesion records, sums and response categories that your imaging reader supplies, with dates and an audit trail. It does not read images or apply RECIST itself.
Does it support thyroglobulin and TSH series?
Yes, as lab fields with units and reference ranges across visits. Your protocol defines the response thresholds; an edit check can flag missing antibody results.
Can it connect to our central lab or imaging vendor?
No integration is claimed. Data are entered by site staff, and exports are available for sharing with vendors.
How are targeted-drug dose reductions recorded?
As repeating rows with dose, reason, linked adverse event and date, each with its own audit trail.
Is it suitable for rare medullary or anaplastic disease trials?
Yes for small multi-site studies. Site-level numbering and filtering help a coordinating team; recruitment and regulatory strategy remain yours.
What about patient-reported quality of life?
Questionnaires can be completed on the participant's phone. Bring your own licensed instrument; Capture does not provide or verify licences.
What does it cost?
The sandbox is free with every feature, no credit card. Plans for live studies are on the pricing page.
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Related pages
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