Breast NeoplasmsSELINANCT04014283
Prevention of Female Cancers by Optimization of Selenium Levels in the Organism.
A study testing Diet modification in people with Breast Neoplasms, run by Read-Gene S.A. at 1 site in Poland.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Neoplasms
- What is being tested?
- Diet modification
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 7,000 participants
- Where
- 1 sitePoland
- Study dates
- Oct 2014to Nov 2023
- Phase
- Interventional
- 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 21 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Show all 19Show fewer
- 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
Who cannot join
- 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
Show all 18Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Breast Neoplasms
- Being tested
- Selenium supplementation or placebo treatment, Diet modification, Selenium supplementation or placebo treatment and diet modification
- Keywords
- Selenium, Supplement, Prevention, Females, Risk
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Selenium supplementation or placebo treatmentDietary supplement
Patients from this group will receive selenium supplement to achieve optimal selenium level
Diet modificationOther
Patients from this group will have modified diet over the course of the study. Diet modification is aimed to lower selenium concentration in blood.
Selenium supplementation or placebo treatment and diet modificationOther
In this group patients will receive supplement, placebo or diet modification. The goal is to raise selenium concentration in blood
| Study group | Role | What they receive |
|---|---|---|
| BRCA(+) Selenium deficiency | Active comparator | Placebo: 100 Supplement: 100 Receives: Dietary Supplement: Selenium supplementation or placebo treatment |
| BRCA(+) Selenium excess | Active comparator | Diet modification: 500 Observation: 500 Receives: Other: Diet modification |
| BRCA(-) Selenium deficiency | Active comparator | Placebo: 900 Supplement: 900 Diet modification: 900 Observation: 900 Receives: Other: Selenium supplementation or placebo treatment and diet modification |
| BRCA(-) Selenium excess | Active comparator | Diet modification: 1100 Observation: 1100 Receives: Other: Diet modification |
| BRCA(+) Selenium excess, age > 50 | Active comparator | Diet modification: 200 Observation: 200 Receives: Other: Diet modification |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: within 60 months of the study
Secondary outcomes (2)
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.
Measured: within 60 months of the study
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.
Measured: within 60 months of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2019
- Study startOct 2014
- Primary completionNov 2023 (estimated)
- Study completionNov 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (67)Papers the sponsor has linked to this study.
- Other trials for Breast NeoplasmsStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Single blind
- Who is masked
- Investigator
- Enrolment
- 7,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Read-Gene S.A.
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Research and Development, Poland, IQ Pharma S.A., West Pomeranian University of Technology, Vipharm S.A.
- Responsible party
- Principal investigator, Lubinski Jan, Read-Gene S.A.
- Investigators
- Jan Lubiński, MD, PhD, Principal investigator, Read-Gene S.A.Cezary Cybulski, MD, PhD, Study chair, Read-Gene S.A.Jacek Gronwald, MD, PhD, Study chair, Read-Gene S.A.Tomasz Huzarski, MD, PhD, Study chair, Read-Gene S.A.Anna Jakubowska, MD, PhD, Study chairAntoni Morawski, PhD, Study chairEwa Stachowska, PhD, Study chair, Read-Gene S.A.Edyta Balejko, PhD, Study chair
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04014283
- Sponsor's protocol ID
- INNOMED/I/16?NCBR/2014
- Acronym
- SELINA
- Status last verified
- Apr 2023
- First submitted
- 18 Jun 2019
- Last updated
- 20 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: We still did not collect all the required participants. It is hard to tell that the data could be useful later on.
Publications
Adeoti ML, Oguntola AS, Akanni EO, Agodirin OS, Oyeyemi GM. Trace elements; copper, zinc and selenium, in breast cancer afflicted female patients in LAUTECH Osogbo, Nigeria. Indian J Cancer. 2015 Jan-Mar;52(1):106-9. doi: 10.4103/0019-509X.175573.
PubMed 26837992Algotar AM, Behnejad R, Singh P, Thompson PA, Hsu CH, Stratton SP. EFFECT OF SELENIUM SUPPLEMENTATION ON PROTEOMIC SERUM BIOMARKERS IN ELDERLY MEN. J Frailty Aging. 2015;4(2):107-10. doi: 10.14283/jfa.2015.48.
PubMed 26366377Arnaud J, Arnault N, Roussel AM, Bertrais S, Ruffieux D, Galan P, Favier A, Hercberg S. Relationships between selenium, lipids, iron status and hormonal therapy in women of the SU.VI.M.AX cohort. J Trace Elem Med Biol. 2007;21 Suppl 1:66-9. doi: 10.1016/j.jtemb.2007.09.025. Epub 2007 Oct 22.
PubMed 18039502Barany E, Bergdahl IA, Bratteby LE, Lundh T, Samuelson G, Skerfving S, Oskarsson A. Iron status influences trace element levels in human blood and serum. Environ Res. 2005 Jun;98(2):215-23. doi: 10.1016/j.envres.2004.09.010.
PubMed 15820728Singh BP, Dwivedi S, Dhakad U, Murthy RC, Choubey VK, Goel A, Sankhwar SN. Status and Interrelationship of Zinc, Copper, Iron, Calcium and Selenium in Prostate Cancer. Indian J Clin Biochem. 2016 Mar;31(1):50-6. doi: 10.1007/s12291-015-0497-x. Epub 2015 Apr 16.
PubMed 26855488Bleys J, Navas-Acien A, Guallar E. Serum selenium levels and all-cause, cancer, and cardiovascular mortality among US adults. Arch Intern Med. 2008 Feb 25;168(4):404-10. doi: 10.1001/archinternmed.2007.74.
PubMed 18299496Borawska MH, Socha K, Lazarczyk B, Czyzewska E, Markiewicz R, Darewicz B. The effects of diet on selenium concentration in serum in patients with cancer. Nutr Cancer. 2009;61(5):629-33. doi: 10.1080/01635580902825555.
PubMed 19838936Chareonpong-Kawamoto N, Yasumoto K. Selenium deficiency as a cause of overload of iron and unbalanced distribution of other minerals. Biosci Biotechnol Biochem. 1995 Feb;59(2):302-6. doi: 10.1271/bbb.59.302.
PubMed 7766029Chmielnicka J, Zareba G, Witasik M, Brzeznicka E. Zinc-selenium interaction in the rat. Biol Trace Elem Res. 1988 Jan-Apr;15:267-76. doi: 10.1007/BF02990143.
PubMed 2484524Clark LC, Combs GF Jr, Turnbull BW, Slate EH, Chalker DK, Chow J, Davis LS, Glover RA, Graham GF, Gross EG, Krongrad A, Lesher JL Jr, Park HK, Sanders BB Jr, Smith CL, Taylor JR. Effects of selenium supplementation for cancer prevention in patients with carcinoma of the skin. A randomized controlled trial. Nutritional Prevention of Cancer Study Group. JAMA. 1996 Dec 25;276(24):1957-63.
PubMed 8971064Coates RJ, Weiss NS, Daling JR, Morris JS, Labbe RF. Serum levels of selenium and retinol and the subsequent risk of cancer. Am J Epidemiol. 1988 Sep;128(3):515-23. doi: 10.1093/oxfordjournals.aje.a114999.
PubMed 3046338Combs GF Jr, Gray WP. Chemopreventive agents: selenium. Pharmacol Ther. 1998 Sep;79(3):179-92. doi: 10.1016/s0163-7258(98)00014-x.
PubMed 9776375Combs GF Jr, Clark LC, Turnbull BW. An analysis of cancer prevention by selenium. Biofactors. 2001;14(1-4):153-9. doi: 10.1002/biof.5520140120.
PubMed 11568452Constantinescu S, Hecht K, Sobotzki N, Erzinger MM, Bovet C, Shay JW, Wollscheid B, Sturla SJ, Marra G, Beerenwinkel N. Transcriptomic responses of cancerous and noncancerous human colon cells to sulforaphane and selenium. Chem Res Toxicol. 2014 Mar 17;27(3):377-86. doi: 10.1021/tx400427t. Epub 2014 Jan 13.
PubMed 24383545Druesne-Pecollo N, Touvier M, Barrandon E, Chan DS, Norat T, Zelek L, Hercberg S, Latino-Martel P. Excess body weight and second primary cancer risk after breast cancer: a systematic review and meta-analysis of prospective studies. Breast Cancer Res Treat. 2012 Oct;135(3):647-54. doi: 10.1007/s10549-012-2187-1. Epub 2012 Aug 5.
PubMed 22864804
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of Females Malignancies in Families With Hereditary Breast Cancer by Personalized Optimization of Se Levels in the Organism.
- ClinicalTrials.gov ID
- NCT04014283
- Acronym / sponsor ID
- SELINA / INNOMED/I/16?NCBR/2014
- Conditions
- Breast Neoplasms
- Keywords
- Selenium, Supplement, Prevention, Females, Risk
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 7,000 participants (estimated)
- Lead sponsor
- Read-Gene S.A.University, hospital or other
- Collaborators
- National Center for Research and Development, Poland, IQ Pharma S.A., West Pomeranian University of Technology, Vipharm S.A.
- Study start
- Oct 2014 (actual)
- Primary completion
- Nov 2023 (estimated)
- Study completion
- Nov 2023 (estimated)
- First posted
- 10 Jul 2019 (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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 5
- 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.
| Arm | Type | Receives |
|---|---|---|
| BRCA(+) Selenium deficiency | Active comparator | Dietary Supplement: Selenium supplementation or placebo treatmentPlacebo: 100 Supplement: 100 |
| BRCA(+) Selenium excess | Active comparator | Other: Diet modificationDiet modification: 500 Observation: 500 |
| BRCA(-) Selenium deficiency | Active comparator | Other: Selenium supplementation or placebo treatment and diet modificationPlacebo: 900 Supplement: 900 Diet modification: 900 Observation: 900 |
| BRCA(-) Selenium excess | Active comparator | Other: Diet modificationDiet modification: 1100 Observation: 1100 |
| BRCA(+) Selenium excess, age > 50 | Active comparator | Other: Diet modificationDiet modification: 200 Observation: 200 |
Who may qualify
- Ages
- 21 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- 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
Key exclusion criteria (18 listed)
- 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
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 |
|---|---|---|
| Selenium supplementation or placebo treatmentPatients from this group will receive selenium supplement to achieve optimal selenium level | Dietary supplement | BRCA(+) Selenium deficiency |
| Diet modificationPatients from this group will have modified diet over the course of the study. Diet modification is aimed to lower selenium concentration in blood. | Other | BRCA(+) Selenium excess, BRCA(+) Selenium excess, age > 50, BRCA(-) Selenium excess |
| Selenium supplementation or placebo treatment and diet modificationIn this group patients will receive supplement, placebo or diet modification. The goal is to raise selenium concentration in blood | Other | BRCA(-) Selenium deficiency |
Primary outcome
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.
2 secondary outcomes
Development of new breast cancer
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2023.
- Background: PubMed 26837992Adeoti ML, Oguntola AS, Akanni EO, Agodirin OS, Oyeyemi GM. Trace elements; copper, zinc and selenium, in breast cancer afflicted female patients in LAUTECH Osogbo, Nigeria. Indian J Cancer. 2015 Jan-Mar;52(1):106-9. doi: 10.4103/0019-509X.175573.
- Background: PubMed 26366377Algotar AM, Behnejad R, Singh P, Thompson PA, Hsu CH, Stratton SP. EFFECT OF SELENIUM SUPPLEMENTATION ON PROTEOMIC SERUM BIOMARKERS IN ELDERLY MEN. J Frailty Aging. 2015;4(2):107-10. doi: 10.14283/jfa.2015.48.
- Background: PubMed 18039502Arnaud J, Arnault N, Roussel AM, Bertrais S, Ruffieux D, Galan P, Favier A, Hercberg S. Relationships between selenium, lipids, iron status and hormonal therapy in women of the SU.VI.M.AX cohort. J Trace Elem Med Biol. 2007;21 Suppl 1:66-9. doi: 10.1016/j.jtemb.2007.09.025. Epub 2007 Oct 22.
- Background: PubMed 15820728Barany E, Bergdahl IA, Bratteby LE, Lundh T, Samuelson G, Skerfving S, Oskarsson A. Iron status influences trace element levels in human blood and serum. Environ Res. 2005 Jun;98(2):215-23. doi: 10.1016/j.envres.2004.09.010.
- Background: PubMed 26855488Singh BP, Dwivedi S, Dhakad U, Murthy RC, Choubey VK, Goel A, Sankhwar SN. Status and Interrelationship of Zinc, Copper, Iron, Calcium and Selenium in Prostate Cancer. Indian J Clin Biochem. 2016 Mar;31(1):50-6. doi: 10.1007/s12291-015-0497-x. Epub 2015 Apr 16.
- Background: PubMed 18299496Bleys J, Navas-Acien A, Guallar E. Serum selenium levels and all-cause, cancer, and cardiovascular mortality among US adults. Arch Intern Med. 2008 Feb 25;168(4):404-10. doi: 10.1001/archinternmed.2007.74.
- Background: PubMed 19838936Borawska MH, Socha K, Lazarczyk B, Czyzewska E, Markiewicz R, Darewicz B. The effects of diet on selenium concentration in serum in patients with cancer. Nutr Cancer. 2009;61(5):629-33. doi: 10.1080/01635580902825555.
- Background: PubMed 7766029Chareonpong-Kawamoto N, Yasumoto K. Selenium deficiency as a cause of overload of iron and unbalanced distribution of other minerals. Biosci Biotechnol Biochem. 1995 Feb;59(2):302-6. doi: 10.1271/bbb.59.302.
- Background: PubMed 2484524Chmielnicka J, Zareba G, Witasik M, Brzeznicka E. Zinc-selenium interaction in the rat. Biol Trace Elem Res. 1988 Jan-Apr;15:267-76. doi: 10.1007/BF02990143.
- Background: PubMed 8971064Clark LC, Combs GF Jr, Turnbull BW, Slate EH, Chalker DK, Chow J, Davis LS, Glover RA, Graham GF, Gross EG, Krongrad A, Lesher JL Jr, Park HK, Sanders BB Jr, Smith CL, Taylor JR. Effects of selenium supplementation for cancer prevention in patients with carcinoma of the skin. A randomized controlled trial. Nutritional Prevention of Cancer Study Group. JAMA. 1996 Dec 25;276(24):1957-63.
- Background: PubMed 3046338Coates RJ, Weiss NS, Daling JR, Morris JS, Labbe RF. Serum levels of selenium and retinol and the subsequent risk of cancer. Am J Epidemiol. 1988 Sep;128(3):515-23. doi: 10.1093/oxfordjournals.aje.a114999.
- Background: PubMed 9776375Combs GF Jr, Gray WP. Chemopreventive agents: selenium. Pharmacol Ther. 1998 Sep;79(3):179-92. doi: 10.1016/s0163-7258(98)00014-x.
- 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 CancerLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided. 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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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.
Jan Lubiński, MD, PhD principal investigator
Read-Gene S.A.
Cezary Cybulski, MD, PhD study chair
Read-Gene S.A.
Jacek Gronwald, MD, PhD study chair
Read-Gene S.A.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diet modification in people with Breast Neoplasms, run by Read-Gene S.A. at 1 site in Poland.
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 19 inclusion and 18 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: status not confirmed, as of the sponsor's last update on 20 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
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?
Development of any new cancer (time frame: within 60 months of the study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04014283, which also lists 67 linked publications.
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 20 Apr 2023.