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

Primary Purpose

Breast Neoplasms

Status
Active
Phase
Not Applicable
Locations
Poland
Study Type
Interventional
Intervention
Selenium supplementation or placebo treatment
Diet modification
Selenium supplementation or placebo treatment and diet modification
Sponsored by
Read-Gene S.A.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Breast Neoplasms focused on measuring Selenium, Supplement, Prevention, Females, Risk

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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)

Sites / Locations

  • Read-Gene S.A.

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

BRCA(+) Selenium deficiency

BRCA(+) Selenium excess

BRCA(-) Selenium deficiency

BRCA(-) Selenium excess

BRCA(+) Selenium excess, age > 50

Arm Description

Placebo: 100 Supplement: 100

Diet modification: 500 Observation: 500

Placebo: 900 Supplement: 900 Diet modification: 900 Observation: 900

Diet modification: 1100 Observation: 1100

Diet modification: 200 Observation: 200

Outcomes

Primary Outcome Measures

Development of any new cancer
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.

Secondary Outcome Measures

Development of new breast cancer
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.
Proportion of any other cancers (besides breast cancers) at the end of 60 months
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.

Full Information

First Posted
June 18, 2019
Last Updated
April 19, 2023
Sponsor
Read-Gene S.A.
Collaborators
National Center for Research and Development, Poland, IQ Pharma S.A., West Pomeranian University of Technology, Vipharm S.A.
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1. Study Identification

Unique Protocol Identification Number
NCT04014283
Brief Title
Prevention of Female Cancers by Optimization of Selenium Levels in the Organism.
Acronym
SELINA
Official Title
Prevention of Females Malignancies in Families With Hereditary Breast Cancer by Personalized Optimization of Se Levels in the Organism.
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
October 2014 (Actual)
Primary Completion Date
November 2023 (Anticipated)
Study Completion Date
November 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Read-Gene S.A.
Collaborators
National Center for Research and Development, Poland, IQ Pharma S.A., West Pomeranian University of Technology, Vipharm S.A.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Neoplasms
Keywords
Selenium, Supplement, Prevention, Females, Risk

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Supplementation of selenium or diet modification will be effective in reducing the risk of developing breast cancer in women with high risk, as compared to placebo. The null hypothesis assumes no significant differences between the supplementation and placebo groups. The alternative hypothesis assumes that patients with high risk of breast cancer in supplementation or diet modification group with optimal selenium level will have significantly reduced risk of developing cancer in relation to the placebo group with selenium deficiency. The comparison of disease-free survival time intervals is best covered by Cox Regression and is represented by a Kaplan-Meier survival curve tested by log- rank test. The comparison of proportions of diseased and healthy subjects in the supplementation arm with respect to the placebo arm is best attempted using the Fisher Exact Test. Graphical representation should be based on bar plots for percentages and/or raw numbers, or a similar representation.
Masking
Investigator
Masking Description
The selected randomization method is block randomization with randomly chosen blocks sizes. Randomization must take place before 120 days after the Screening Visit (Day 0). After confirmation that the patient meets all eligibility criteria for the study, the patient will be randomly assigned (1:1) to either placebo or supplementation group. Patients with selenium deficiency can choose between diet modification and supplementation group. The last step of randomisation is the blinding/assigning procedure - connecting randomization numbers with placebo or supplement packages numbers and assigning them to the subjects. All SELINA personnel, participants and clinicians will be blinded to the treatment allocation; only the Statistical Center will have the possibility to unblind the data.
Allocation
Randomized
Enrollment
7000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
BRCA(+) Selenium deficiency
Arm Type
Active Comparator
Arm Description
Placebo: 100 Supplement: 100
Arm Title
BRCA(+) Selenium excess
Arm Type
Active Comparator
Arm Description
Diet modification: 500 Observation: 500
Arm Title
BRCA(-) Selenium deficiency
Arm Type
Active Comparator
Arm Description
Placebo: 900 Supplement: 900 Diet modification: 900 Observation: 900
Arm Title
BRCA(-) Selenium excess
Arm Type
Active Comparator
Arm Description
Diet modification: 1100 Observation: 1100
Arm Title
BRCA(+) Selenium excess, age > 50
Arm Type
Active Comparator
Arm Description
Diet modification: 200 Observation: 200
Intervention Type
Dietary Supplement
Intervention Name(s)
Selenium supplementation or placebo treatment
Intervention Description
Patients from this group will receive selenium supplement to achieve optimal selenium level
Intervention Type
Other
Intervention Name(s)
Diet modification
Intervention Description
Patients from this group will have modified diet over the course of the study. Diet modification is aimed to lower selenium concentration in blood.
Intervention Type
Other
Intervention Name(s)
Selenium supplementation or placebo treatment and diet modification
Intervention Description
In this group patients will receive supplement, placebo or diet modification. The goal is to raise selenium concentration in blood
Primary Outcome Measure Information:
Title
Development of any new cancer
Description
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.
Time Frame
within 60 months of the study
Secondary Outcome Measure Information:
Title
Development of new breast cancer
Description
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.
Time Frame
within 60 months of the study
Title
Proportion of any other cancers (besides breast cancers) at the end of 60 months
Description
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.
Time Frame
within 60 months of the study

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: - Sub-group I - BRCA1 mutation carriers Carrier-status of BRCA1 mutation Age >20 years Have a breast magnetic resonance imaging and/or ultrasonography and/or mammography that reveals no disease at maximum 9 months after enrollment Be able to give information consent and sign an informed consent form Be willing to comply with all of the study procedures as per the protocol Be willing to inform researchers about current or any new pregnancy Sub-optimal Se level in the blood Sub-group II - Females from families with hereditary breast cancers but without BRCA1 mutations Age ≥40 years Age ≥20 years for women that have been diagnosed previously with breast cancer Positive medical history of family, matching criteria of hereditary breast/ovarian cancer (HBO) (Appendix 1) No personal history of cancer except for breast cancer and non-melanoma skin cancers Have a breast magnetic resonance imaging/ultrasonography/mammography that reveals no disease at maximum 9 months after enrollment Be able to give information consent and sign an informed consent form Absence of BRCA1 mutations after testing for at least three founder mutations (BRCA1 5382insC, BRCA1 300T/G, BRCA1 4154delA) Be willing to comply with all of the study procedures as per the protocol Be willing to inform researchers about current or any new pregnancy Sub-optimal Se level in the blood Exclusion Criteria: Sub-group I - BRCA1 mutation carriers Diagnosis of any previous cancer except for breast cancers and non-melanoma skin cancers Absence of a magnetic resonance imaging/ultrasonography/mammography that reveals no disease at maximum 9 months after enrollment Current pregnancy or breast-feeding Optimal Se level in the blood Age <20 years Any medical illness, which, in the investigator's opinion, cannot be adequately controlled with appropriate therapy 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 Diagnosis of any previous cancer except for breast cancers and non-melanoma skin cancers Absence of magnetic resonance imaging and/or ultrasonography and/or mammography that reveals no disease at maximum 9 months after enrollment Absence of matching pedigree/clinical/molecular criteria of HBO (Appendix 1) Presence of BRCA1 mutation Current pregnancy or breast-feeding Optimal Se level in the blood Age <40 years except for women that have been previously diagnosed with breast cancer Any medical illness, which, in the investigator's opinion, cannot be adequately controlled with appropriate therapy 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jan Lubiński, MD, PhD
Organizational Affiliation
Read-Gene S.A.
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Cezary Cybulski, MD, PhD
Organizational Affiliation
Read-Gene S.A.
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Jacek Gronwald, MD, PhD
Organizational Affiliation
Read-Gene S.A.
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Tomasz Huzarski, MD, PhD
Organizational Affiliation
Read-Gene S.A.
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Anna Jakubowska, MD, PhD
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Antoni Morawski, PhD
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Ewa Stachowska, PhD
Organizational Affiliation
Read-Gene S.A.
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Edyta Balejko, PhD
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Karolina Ertmańska, PhD
Official's Role
Study Chair
Facility Information:
Facility Name
Read-Gene S.A.
City
Grzepnica
State/Province
West Pomerania
ZIP/Postal Code
72-003
Country
Poland

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
We still did not collect all the required participants. It is hard to tell that the data could be useful later on.
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Links:
URL
https://www.nice.org.uk/guidance/cg164/evidence
Description
Clinical Guidelines for the classification and care of women at risk of familial breast cancer in primary, secondary and tertiary care, NICE, 2013, National Collaborating Centre for Cancer

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

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