Outcome of Breast CancerNCT03669952
Study of the Influence of Ductal Carcinoma in Situ on the Outcome of Invasive Breast Cancer
An observational study of Outcome of Breast Cancer, run by Omphis Foundation.
Trial summary
A prospective observational longitudinal study of 464 patients was performed between 2010 and 2015. Patients with invasive ductal carcinoma (IDC) and ductal carcinoma in situ associated to invasive ductal carcinoma (DCIS +IDC) were included and analyzed. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Outcome of Breast Cancer
- What is being tested?
- None intervention
- How many people
- 464 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2010to 31 Dec 2015
- How long will I take part?
- 7 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The population included in the study was 464 patients. IDC was present in 221 patients (47.6%) and IDC + DCIS was present in 243 patients (52.4%).
Who may be able to join
- Patients with invasive ductal carcinoma of the breast
- Patients who received surgery for primary invasive breast cancer between 2010 and 2015
Who cannot join
- Patients with metastasis at the diagnostic
About this study
Official title: Longitudinal Observational Study About the Influence of Ductal Carcinoma in Situ on the Outcome of Invasive Breast Cancer
A prospective observational longitudinal study of 464 patients was performed between 2010 and 2015. Patients with invasive ductal carcinoma (IDC) and ductal carcinoma in situ associated to invasive ductal carcinoma (DCIS +IDC) were included and analyzed.
Read the detailed description
Type of study:
A prospective observational longitudinal study was performed on patients who had undergone curative surgery for primary invasive breast cancer between 2010 and 2015. The study was performed in a single breast pathology unit [Alt Penedés hospital and Sant Camil hospital(GAP)]. Only patients with a definitive histopathology-based diagnostic of ductal carcinoma were included. Patients diagnosed with metastasis were excluded. Patients with bilateral breast cancer were included as two independent study cases.
Patients:
Sample size calculation: 191. A total of 464 patients were included in the study. IDC was present in 221 patients (47.6%) and IDC + DCIS was present in 243 patients (52.4%).
Data collected included clinical characteristics (age, laterality and clinical symptoms at the time of diagnostic), histopathological information (tumor size, tumor grade, hormone receptors, nodal status, HER-2 mutation (erb-b2 receptor tyrosine kinase 2), number of ki67, presence and percentage of DCIS, grade of DCIS, and surrogate subtype) and surgical procedure performed.
Tumor histopathology and the number of lymph nodes involved were evaluated by routine hematoxylin-eosin (H\&E) staining. The histological response to chemotherapy was assessed according to Miller-Payne criteria of grading (MPG) and Residual Disease in Breast and Nodes (RDBN).
The percentage of DCIS and its grade (classified as low, intermediate or high) was measured by two independent pathologists.
Statistical analysis:
Quantitative data are shown as the median or mean of values and their variability is expressed as the range or standard deviation (SD), as specified for each analysis. Qualitative data are shown as absolute values or percentages. The incidence was used as a measure of frequency and the relative risk as a measure of association between independent groups.
The study of the normality of quantitative variables was done applying the Kolmogorov-Smirnov or the Shapiro-Wilk tests, as indicated for each analysis. For significance assessment of quantitative data, unpaired Student's T-test or two-tailed Mann-Whitney U test was applied, as specified for each analysis. For significance assessment of qualitative data, Fisher's exact test or Chi-squared test was applied. For the analysis of more than two groups, one-way ANOVA and Tukey's range test for post hoc pairwise comparison of groups, or Kruskal-Wallis were used. Survival was analyzed with the Kaplan-Meier estimate and survival distributions compared with the Log-Rank test. Multivariate Cox proportional hazards regression model was used to simultaneously evaluate the effect of several factors on survival and mortality.
Statistical analysis was performed using the software SPSS® (Statistical Package for the Social Sciences) version 21.
The aim of the investigator's study is to compare the clinical and histopathological factors between patients with IDC or DCIS-associated IDC (IDC + DCIS) and find the prognostic factors associated to recurrence and mortality in each group.
- Conditions
- Outcome of Breast Cancer
- Being tested
- None intervention
- Keywords
- Breast cancer, Ductal carcinoma in situ, Invasive ductal carcinoma, Prognosis factors
- Medical subject headings
- Breast Neoplasms, Carcinoma, Intraductal, Noninfiltrating
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
None interventionOther
No interventions are realized, only observational study
| Study group | Role | What they receive |
|---|---|---|
| Invasive ductal carcinoma | Patients with Invasive ductal carcinoma Receives: Other: None intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence
Neoplasm metastasis, either local or distant recurrence of the invasive ductal carcinoma
Measured: Patients included between 2010 and 2015 will be follow up til January of 2018 with a mean follow up of 51.43 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2018
- Study start1 Jan 2010
- Primary completion31 Dec 2015
- Study completion31 Dec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Outcome of Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 464 participants (actual)
- Target duration
- 7 Years
Sponsor and investigators
- Lead sponsor
- Omphis Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sandra Lopez Gordo, Omphis Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03669952
- Sponsor's protocol ID
- SLG_01
- Status last verified
- Sep 2018
- First submitted
- 11 Sep 2018
- Last updated
- 17 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Longitudinal Observational Study About the Influence of Ductal Carcinoma in Situ on the Outcome of Invasive Breast Cancer
- ClinicalTrials.gov ID
- NCT03669952
- Acronym / sponsor ID
- SLG_01
- Conditions
- Outcome of Breast Cancer
- Keywords
- Breast cancer, Ductal carcinoma in situ, Invasive ductal carcinoma, Prognosis factors
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 464 participants (actual)
- Lead sponsor
- Omphis FoundationUniversity, hospital or other
- Study start
- 1 Jan 2010 (actual)
- Primary completion
- 31 Dec 2015 (actual)
- Study completion
- 31 Dec 2015 (actual)
- First posted
- 13 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A prospective observational longitudinal study of 464 patients was performed between 2010 and 2015. Patients with invasive ductal carcinoma (IDC) and ductal carcinoma in situ associated to invasive ductal carcinoma (DCIS +IDC) were included and analyzed.
Detailed description
Type of study:
A prospective observational longitudinal study was performed on patients who had undergone curative surgery for primary invasive breast cancer between 2010 and 2015. The study was performed in a single breast pathology unit [Alt Penedés hospital and Sant Camil hospital(GAP)]. Only patients with a definitive histopathology-based diagnostic of ductal carcinoma were included. Patients diagnosed with metastasis were excluded. Patients with bilateral breast cancer were included as two independent study cases.
Patients:
Sample size calculation: 191. A total of 464 patients were included in the study. IDC was present in 221 patients (47.6%) and IDC + DCIS was present in 243 patients (52.4%).
Data collected included clinical characteristics (age, laterality and clinical symptoms at the time of diagnostic), histopathological information (tumor size, tumor grade, hormone receptors, nodal status, HER-2 mutation (erb-b2 receptor tyrosine kinase 2), number of ki67, presence and percentage of DCIS, grade of DCIS, and surrogate subtype) and surgical procedure performed.
Tumor histopathology and the number of lymph nodes involved were evaluated by routine hematoxylin-eosin (H\&E) staining. The histological response to chemotherapy was assessed according to Miller-Payne criteria of grading (MPG) and Residual Disease in Breast and Nodes (RDBN).
The percentage of DCIS and its grade (classified as low, intermediate or high) was measured by two independent pathologists.
Statistical analysis:
Quantitative data are shown as the median or mean of values and their variability is expressed as the range or standard deviation (SD), as specified for each analysis. Qualitative data are shown as absolute values or percentages. The incidence was used as a measure of frequency and the relative risk as a measure of association between independent groups.
The study of the normality of quantitative variables was done applying the Kolmogorov-Smirnov or the Shapiro-Wilk tests, as indicated for each analysis. For significance assessment of quantitative data, unpaired Student's T-test or two-tailed Mann-Whitney U test was applied, as specified for each analysis. For significance assessment of qualitative data, Fisher's exact test or Chi-squared test was applied. For the analysis of more than two groups, one-way ANOVA and Tukey's range test for post hoc pairwise comparison of groups, or Kruskal-Wallis were used. Survival was analyzed with the Kaplan-Meier estimate and survival distributions compared with the Log-Rank test. Multivariate Cox proportional hazards regression model was used to simultaneously evaluate the effect of several factors on survival and mortality.
Statistical analysis was performed using the software SPSS® (Statistical Package for the Social Sciences) version 21.
The aim of the investigator's study is to compare the clinical and histopathological factors between patients with IDC or DCIS-associated IDC (IDC + DCIS) and find the prognostic factors associated to recurrence and mortality in each group.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 7 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Invasive ductal carcinoma | – | Other: None interventionPatients with Invasive ductal carcinoma |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The population included in the study was 464 patients. IDC was present in 221 patients (47.6%) and IDC + DCIS was present in 243 patients (52.4%).
Key inclusion criteria (2 listed)
- Patients with invasive ductal carcinoma of the breast
- Patients who received surgery for primary invasive breast cancer between 2010 and 2015
Key exclusion criteria (1 listed)
- Patients with metastasis at the diagnostic
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| None interventionNo interventions are realized, only observational study | Other | Invasive ductal carcinoma |
Primary outcome
Recurrence
Time frame: Patients included between 2010 and 2015 will be follow up til January of 2018 with a mean follow up of 51.43 months
Neoplasm metastasis, either local or distant recurrence of the invasive ductal carcinoma
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Outcome of Breast Cancer, run by Omphis Foundation.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrence (time frame: Patients included between 2010 and 2015 will be follow up til January of 2018 with a mean follow up of 51.43 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2018.