Trial Outcomes & Findings for Gene Expression in Tumor Tissue From Women Undergoing Surgery for Breast Cancer or Core Biopsy of the Breast (NCT NCT00898937)
NCT ID: NCT00898937
Last Updated: 2018-04-13
Results Overview
Concentration of RNA recovered from breast needle biopsies
Recruitment status
TERMINATED
Target enrollment
55 participants
Primary outcome timeframe
1 day
Results posted on
2018-04-13
Participant Flow
Participant milestones
| Measure |
Snap-frozen
Method of RNA recovery: Snap-frozen
For more information about snap-frozen RNA recovery please see this link:
https://www.thermofisher.com/us/en/home/references/ambion-tech-support/rna-isolation/tech-notes/effect-of-freeze-thawing-of-tissue-on-rna-integrity.html
|
RNALater
Method of RNA recovery: RNALater
For more information on RNAlater please see this link: https://www.thermofisher.com/us/en/home/brands/product-brand/rnalater.html
|
Method of RNA recovery: unknown
|
|---|---|---|---|
|
Overall Study
STARTED
|
25
|
21
|
9
|
|
Overall Study
COMPLETED
|
25
|
21
|
9
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Snap-frozen
n=25 Participants
Method of RNA recovery: Snap-frozen
|
RNALater
n=21 Participants
Method of RNA recovery: RNALater
|
Unknown
n=9 Participants
Method of RNA recovery: unknown
|
Total
n=55 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=25 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=55 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
25 Participants
n=25 Participants
|
21 Participants
n=21 Participants
|
9 Participants
n=9 Participants
|
55 Participants
n=55 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=25 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=55 Participants
|
|
Sex: Female, Male
Female
|
25 Participants
n=25 Participants
|
21 Participants
n=21 Participants
|
9 Participants
n=9 Participants
|
55 Participants
n=55 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=25 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=55 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
PRIMARY outcome
Timeframe: 1 dayConcentration of RNA recovered from breast needle biopsies
Outcome measures
| Measure |
Snap-frozen
n=25 Participants
Method of RNA recovery: Snap-frozen
|
RNALater
n=21 Participants
Method of RNA recovery: RNALater
|
Unknown
n=9 Participants
Method of RNA recovery: unknown
|
|---|---|---|---|
|
Tumor Gene Expression as Assessed by RNA Microarray Analysis
|
2.04 micrograms
Standard Error 0.51
|
3.49 micrograms
Standard Error 0.78
|
3.63 micrograms
Standard Error 0.48
|
Adverse Events
Snap-frozen
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
RNALater
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Claudine Isaacs
Georgetown University Medical Center - Lombardi Comprehensive Cancer Center
Phone: 202-444-3677
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place