Clinical trial · Observational
Study of Biomarkers in Blood and/or Tumor Tissue Samples From Patients With Ductal Carcinoma in Situ and From Healthy Volunteers
ICICLE- A Study to Investigate the genetiCs of In Situ Carcinoma of the ductaL subtypE
NCT00935233CI-TRIAL-00011715unknownClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
RATIONALE: Studying genes in samples of blood and/or tumor tissue from patients with cancer may help doctors identify biomarkers related to cancer. PURPOSE: This research study is looking at blood and/or tumor tissue samples from patients with ductal carcinoma in situ and blood samples from healthy volunteers.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| DNA analysis | Genetic | — | UNRESOLVED |
| laboratory biomarker analysis | Other | — | UNRESOLVED |
| polymorphism analysis | Genetic | — | UNRESOLVED |
| protein analysis | Genetic | — | UNRESOLVED |
| questionnaire administration | Other | — | UNRESOLVED |
| survey administration | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (4)
- measure
- Collection of blood and/or tumor tissue
- measure
- Frequency of genetic variants that predispose women to develop ductal carcinoma in situ (DCIS)
- measure
- Effect of these variants on tumor risk
- measure
- Benefit of testing for these variants
Secondary outcomes (1)
- measure
- Analysis of acquired genetic changes within DCIS
Eligibility
Eligibility (as posted)
- Sex
- Female
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Prior or current diagnosis of pure ductal carcinoma in situ (DCIS) * Age ≤ 60 years at the time of diagnosis * DCIS with contralateral synchronous or asynchronous invasive breast cancer is permitted * DCIS associated with microinvasion (foci \< 1 mm) is permitted * Healthy age- and ethnicity-matched controls * No history of DCIS * No relative (up to second degree) diagnosed with DCIS PATIENT CHARACTERISTICS: * Not specified PRIOR CONCURRENT THERAPY: * Not specified
References
Publications (0)
Data not yet available
No reference posted for this study.