Clinical trial · Observational
Feasibility Study of Genomic Profiling Methods and Timing in Tumor Samples
A Feasibility Study of Genomic Profiling Methods and Timing of Sample Collection to Evaluate Clonal Evolution and Tumor Heterogeneity
NCT01703585CI-TRIAL-00032851completedClinicalTrials.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)
This is a feasibility study to look for genetic alterations in tissue and blood samples that may be useful in determining what treatments may be useful in the patient's cancer care.
Conditions
Conditions (6)
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 |
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
| Eligible for Phase I or Phase II Study | — | UNRESOLVED | — |
| Gynecological Cancer | — | UNRESOLVED | — |
| Melanoma Cancer | — | UNRESOLVED | — |
| Metastatic | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (4)
- label
- metastatic breast cancer
- label
- metastatic colorectal cancer
- label
- metastatic gynecological cancer
- label
- metastatic melanoma
Primary outcomes (1)
- measure
- Patient recruitment for paired core and fine needle biopsy greater than or equal to 50% of those screened or approached.
- timeFrame
- 2 years
Secondary outcomes (5)
- measure
- The rate of acceptable tumor samples from fresh core needle biopsy samples/total number of fresh core needle biopsy samples greater than or equal to 90%
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age ≥ 18 years. * Histological or cytological proof of either metastatic breast, colorectal, gynecological or melanoma malignancy. * At least one biopsiable lesion deemed medically accessible and safe to biopsy. * Candidate for one or more phase I or II clinical trials at the time of study enrollment or at a later time point. * Fulfills local institution's laboratory parameters for tumor biopsy. * Willingness and ability of patient to provide signed voluntary informed consent. Exclusion Criteria: * Any condition that could interfere with a patient's ability to provide informed consent such as dementia or severe cognitive impairment. * Any contraindication to undergoing a biopsy procedure.
References
Publications (0)
Data not yet available
No reference posted for this study.