Prevention of Female Cancers by Optimization of Selenium Levels in the Organism. (SELINA)

April 19, 2023 updated by: Lubinski Jan, Read-Gene S.A.

Prevention of Females Malignancies in Families With Hereditary Breast Cancer by Personalized Optimization of Se Levels in the Organism.

Hypothesis to be tested:

Oral supplementation or diet modifications of selenium to a specified range will be effective in reducing the risk of developing cancer of any type in women with high risk of breast cancer, as compared to placebo.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

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

Primary Objective

• To determine the efficacy of oral daily supplementation or diet modification of selenium to an optimal level compared to placebo, in reducing the incidence of any cancers in an at risk population of women over the 60 months of the study.

Secondary Objectives

  • To determine the efficacy of oral daily supplementation or diet modification of selenium to an optimal level compared to placebo, in reducing the incidence of breast cancer in an at risk population of women over the 60 months of the study.
  • To explore the relationship between the effects of study supplement or diet modifications on cancer risk and genetic factors.

The study will have 7000 participants. All the measurements will be performed via blood tests.

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.
Interventional

Enrollment (Anticipated)

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.
7000

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Poland
    • West Pomerania
      • Grzepnica, West Pomerania, Poland, 72-003
        • Read-Gene S.A.

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

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

- Sub-group I - BRCA1 mutation carriers

  1. Carrier-status of BRCA1 mutation
  2. Age >20 years
  3. Have a breast magnetic resonance imaging and/or ultrasonography and/or mammography that reveals no disease at maximum 9 months after enrollment
  4. Be able to give information consent and sign an informed consent form
  5. Be willing to comply with all of the study procedures as per the protocol
  6. Be willing to inform researchers about current or any new pregnancy
  7. Sub-optimal Se level in the blood

Sub-group II - Females from families with hereditary breast cancers but without BRCA1 mutations

  1. Age ≥40 years
  2. Age ≥20 years for women that have been diagnosed previously with breast cancer
  3. Positive medical history of family, matching criteria of hereditary breast/ovarian cancer (HBO) (Appendix 1)
  4. No personal history of cancer except for breast cancer and non-melanoma skin cancers
  5. Have a breast magnetic resonance imaging/ultrasonography/mammography that reveals no disease at maximum 9 months after enrollment
  6. Be able to give information consent and sign an informed consent form
  7. Absence of BRCA1 mutations after testing for at least three founder mutations (BRCA1 5382insC, BRCA1 300T/G, BRCA1 4154delA)
  8. Be willing to comply with all of the study procedures as per the protocol
  9. Be willing to inform researchers about current or any new pregnancy
  10. Sub-optimal Se level in the blood

Exclusion Criteria:

Sub-group I - BRCA1 mutation carriers

  1. Diagnosis of any previous cancer except for breast cancers and non-melanoma skin cancers
  2. Absence of a magnetic resonance imaging/ultrasonography/mammography that reveals no disease at maximum 9 months after enrollment
  3. Current pregnancy or breast-feeding
  4. Optimal Se level in the blood
  5. Age <20 years
  6. Any medical illness, which, in the investigator's opinion, cannot be adequately controlled with appropriate therapy
  7. Participation in any other clinical study involving a medical, surgical, nutritional, or life-style intervention (unless individuals are no longer receiving any intervention and they are in the follow-up phase only)

Sub-group II - Females from families with hereditary breast cancers but without BRCA1 mutations

  1. Diagnosis of any previous cancer except for breast cancers and non-melanoma skin cancers
  2. Absence of magnetic resonance imaging and/or ultrasonography and/or mammography that reveals no disease at maximum 9 months after enrollment
  3. Absence of matching pedigree/clinical/molecular criteria of HBO (Appendix 1)
  4. Presence of BRCA1 mutation
  5. Current pregnancy or breast-feeding
  6. Optimal Se level in the blood
  7. Age <40 years except for women that have been previously diagnosed with breast cancer
  8. Any medical illness, which, in the investigator's opinion, cannot be adequately controlled with appropriate therapy
  9. Participation in any other clinical study involving a medical, surgical, nutritional, or life-style intervention (unless individuals are no longer receiving any intervention and they are in the follow-up phase only)

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

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
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.
Active Comparator: BRCA(+) Selenium deficiency
Placebo: 100 Supplement: 100
Dietary supplement: Selenium supplementation or placebo treatment
Patients from this group will receive selenium supplement to achieve optimal selenium level
Active Comparator: BRCA(+) Selenium excess
Diet modification: 500 Observation: 500
Other: Diet modification
Patients from this group will have modified diet over the course of the study. Diet modification is aimed to lower selenium concentration in blood.
Active Comparator: BRCA(-) Selenium deficiency
Placebo: 900 Supplement: 900 Diet modification: 900 Observation: 900
Other: Selenium supplementation or placebo treatment and diet modification
In this group patients will receive supplement, placebo or diet modification. The goal is to raise selenium concentration in blood
Active Comparator: BRCA(-) Selenium excess
Diet modification: 1100 Observation: 1100
Other: Diet modification
Patients from this group will have modified diet over the course of the study. Diet modification is aimed to lower selenium concentration in blood.
Active Comparator: BRCA(+) Selenium excess, age > 50
Diet modification: 200 Observation: 200
Other: Diet modification
Patients from this group will have modified diet over the course of the study. Diet modification is aimed to lower selenium concentration in blood.

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
Development of any new cancer
Time Frame: within 60 months of the study
Cancer diagnosis will be determined by routine clinical management and confirmed by central pathology review. Cancer-free survival is defined as the period of time between randomization and diagnosis of cancer, or - for patients who do not develop cancer - the period of time between randomization and last contact or death unrelated to cancer.
within 60 months of the study

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Development of new breast cancer
Time Frame: within 60 months of the study
Cancer diagnosis will be determined by routine clinical management and confirmed by central pathology review. Cancer-free survival is defined as the period of time between randomization and diagnosis of cancer, or - for patients who do not develop cancer - the period of time between randomization and last contact or death unrelated to cancer.
within 60 months of the study
Proportion of any other cancers (besides breast cancers) at the end of 60 months
Time Frame: within 60 months of the study
Cancer diagnosis will be determined by routine clinical management and confirmed by central pathology review. Cancer-free survival is defined as the period of time between randomization and diagnosis of cancer, or - for patients who do not develop cancer - the period of time between randomization and last contact or death unrelated to cancer.
within 60 months of the study

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.
Read-Gene S.A.

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Center for Research and Development, Poland
IQ Pharma S.A.
West Pomeranian University of Technology
Vipharm S.A.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

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.
October 1, 2014

Primary Completion (Anticipated)

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.
November 1, 2023

Study Completion (Anticipated)

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.
November 1, 2023

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).
June 18, 2019

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.
July 9, 2019

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.
July 10, 2019

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.
April 20, 2023

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.
April 19, 2023

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.
April 1, 2023

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.
  • INNOMED/I/16?NCBR/2014

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

We still did not collect all the required participants. It is hard to tell that the data could be useful later on.

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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