Study of the Influence of Ductal Carcinoma in Situ on the Outcome of Invasive Breast Cancer

September 13, 2018 updated by: Sandra Lopez Gordo, Omphis Foundation

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
464

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

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%).

Description

Inclusion Criteria:

  • Patients with invasive ductal carcinoma of the breast
  • Patients who received surgery for primary invasive breast cancer between 2010 and 2015

Exclusion Criteria:

  • Patients with metastasis at the diagnostic

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Invasive ductal carcinoma
Patients with Invasive ductal carcinoma
Other: None intervention
No interventions are realized, only observational study

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
Patients included between 2010 and 2015 will be follow up til January of 2018 with a mean follow up of 51.43 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Omphis Foundation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2010

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2015

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 11, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 12, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 13, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 17, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 13, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SLG_01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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