Breast DensityCHiMINCs-IINCT03920098
Chilean Maternal & Infant Cohort Study II (CHiMINCs-II)
An observational study of Breast Density and Body Composition, run by Instituto de Nutrición y Tecnología de los Alimentos at 1 site in Chile.
Trial summary
The Chilean Maternal \& Infant Cohort Study II (ChiMINCs II) is an ongoing cohort that is part of the Chilean Maternal and Infant Nutrition Observatory of the South-East area of Santiago, Chile. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Density, Body Composition, Nutritional Status
- What is being tested?
- Nutrition and mental health during pregnancy
- Type of treatment
- Pill or oral medicine
- How many people
- 1,927 participants
- Where
- 1 siteChile
- Study dates
- 1 Jun 2019to 30 Apr 2023
- 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 18 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: We identified pregnant women who received primary prenatal care within PHCC located in the South East area of Santiago. After, offspring of pregnant women were followed postnatally.
Who may be able to join
- 18 or more years of age
- Gestation <15 weeks at first prenatal visit
- No intention to move outside the city of Santiago in the next to years
Who cannot join
- High-risk pregnancy (i.e., preeclampsia, pre- existing diabetes)
- Pre-existing cancer or family history of breast cancer
- Intended to migrate from the public to the private health care system
Trial locations and contacts
1 site in 1 country.
Chile1 site
Corporación de Salud Municipal de Puente Alto
Santiago, Puente Alto, 8210269
About this study
Official title: The Chilean Maternal and Infant Nutrition Cohort Study II
The Chilean Maternal \& Infant Cohort Study II (ChiMINCs II) is an ongoing cohort that is part of the Chilean Maternal and Infant Nutrition Observatory of the South-East area of Santiago, Chile. In total, 1927 pregnant women beneficiaries of the public health systems and their offspring were recruited before 12 weeks of gestation and are followed across pregnancy (<15, 26-28, and 35-37 weeks of gestation) and up to 2 years of age of their offspring. Two studies are currently nested in ChiMINCs II: 1) Breast Cancer Risk Assessment in Mothers (BRECAM) study, and 2) the ChiMINCs-COVID study. The primary objective of BRECAM study is to test the association between maternal metabolic indicators (i.e., insulin, glucose, IGF-1, and HbAc1 concentrations) at early pregnancy (i.e., <15 and 26-28 weeks of gestation) and breast density 3 months after the cessation of lactation. For this purpose, we collect maternal obstetric, lifestyle, dietary intake, anthropometric, and biochemical information. The aim of the ChiMINCs-COVID study is to assess dietary-related risks and mental health problems derived from the COVID-19 pandemic and their influence on maternal and infant's health and nutrition. Thus, we collected detailed information on dietary behaviors, mental health and COVID-related information at each trimester, along with neonatal and infant nutritional information. The purpose of the present work is to describe the design, methods, and descriptive information at recruitment of ChiMINCs-II, also discussing the implications that this study can have to better understand maternal and infant nutrition and health during the COVID-19 era.
- Being tested
- Nutrition and mental health during pregnancy
- Keywords
- Breast densities, Breast neoplasms, Glucose metabolism disorders, Diabetes, gestational, Pregnancy, Nutritional status, Mental health, Body composition, Growth and development, Primary Health Care, Dual-energy X-ray Absorptiometry, Latin America, Chile
- Medical subject headings
- Breast Neoplasms, Glucose Metabolism Disorders, Diabetes, Gestational, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nutrition and mental health during pregnancyOther
Altered metabolic milieu is defined as a fasting glucose level >100 mg/dL at the first trimester of pregnancy by national guidelines. Altered metabolic milieu during the second trimester (24-28 weeks of pregnancy) is defined as a fasting glucose levels > 92 mg/dL and/or plasma glucose levels > 153 mg/dL two hours after load in the oral glucose tolerance test according to ADA guidelines or a fasting glucose >100 mg/dL and/or > 140 mg/dL two hours after load in the oral glucose tolerance test according to national guidelines. The COVID-19 pandemic is considered as a natural nutritional and mental health exposure.
| Study group | Role | What they receive |
|---|---|---|
| Mother-infant dyads | Mother-infant dyads Receives: Other: Nutrition and mental health during pregnancy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Breast absolute (AFGV) fibro-glandular volume measured by DXA technique
cm3
Measured: Three months after breastfeeding cessation
Breast absolute percentage (%FVG) of fibro-glandular volume measured by DXA technique
percentage
Measured: Three months after breastfeeding cessation
Gestational weight gain
kg
Measured: At delivery
Gestational Diabetes
Percentage of mothers diagnosed
Measured: At delivery
Pregnancy Risk Assessment Monitoring System
Score
Measured: Through the gestation, up the delivery
Edinburg Postnatal Depression Scale
Score
Measured: Through the gestation, up to 6 months
Glucose concentration
mg/dL
Measured: Through the gestation, up the delivery
Insulin concentration
uIU/mL
Measured: Through the gestation, up the delivery
Pandemic Anxiety Scale
Score
Measured: Through the gestation, up the delivery
Secondary outcomes (4)
Offspring weight
g
Measured: At 6 months of age
Offspring length
cm
Measured: At 6 months of age
Offspring head circumference
cm
Measured: At 6 months of age
Offspring body fat
Percentage
Measured: At 6 months of age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2019
- Study start1 Jun 2019
- Primary completion30 Jul 2022 (estimated)
- Study completion30 Apr 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (23)Papers the sponsor has linked to this study.
- Other trials for Breast DensityStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,927 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto de Nutrición y Tecnología de los Alimentos
- Sponsor type
- University, hospital or other
- Collaborators
- Pontificia Universidad Catolica de Chile, Servicio de Salud Metropolitano Sur Oriente
- Responsible party
- Principal investigator, Dr. Maria Luisa Garmendia, Instituto de Nutrición y Tecnología de los Alimentos
- Investigators
- María L Garmendia, PhD, Principal investigator, Instituto de Nutrición y Tecnología de AlimentosCamila L Corvalán Aguilar, PhD, Principal investigator, Institute of Nutrition and Food Technology (INTA), University of Chile, ChileMaría F Mujica Coopman, PhD, Principal investigator, Institute of Nutrition and Food Technology (INTA), University of Chile, Chile
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03920098
- Sponsor's protocol ID
- 1190532
- Acronym
- CHiMINCs-II
- Status last verified
- Feb 2022
- First submitted
- 16 Apr 2019
- Last updated
- 7 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data and blood samples that will be collected in this study will be under the custody of the principal investigator and a human subject protection review board will regulate its use. Others researchers may access the data by contacting to María Luisa Garmendia (Principal Investigator).
Publications
McCormack VA, dos Santos Silva I. Breast density and parenchymal patterns as markers of breast cancer risk: a meta-analysis. Cancer Epidemiol Biomarkers Prev. 2006 Jun;15(6):1159-69. doi: 10.1158/1055-9965.EPI-06-0034.
PubMed 16775176Boyd NF, Guo H, Martin LJ, Sun L, Stone J, Fishell E, Jong RA, Hislop G, Chiarelli A, Minkin S, Yaffe MJ. Mammographic density and the risk and detection of breast cancer. N Engl J Med. 2007 Jan 18;356(3):227-36. doi: 10.1056/NEJMoa062790.
PubMed 17229950Boyd N, Berman H, Zhu J, Martin LJ, Yaffe MJ, Chavez S, Stanisz G, Hislop G, Chiarelli AM, Minkin S, Paterson AD. The origins of breast cancer associated with mammographic density: a testable biological hypothesis. Breast Cancer Res. 2018 Mar 7;20(1):17. doi: 10.1186/s13058-018-0941-y.
PubMed 29514672Li T, Sun L, Miller N, Nicklee T, Woo J, Hulse-Smith L, Tsao MS, Khokha R, Martin L, Boyd N. The association of measured breast tissue characteristics with mammographic density and other risk factors for breast cancer. Cancer Epidemiol Biomarkers Prev. 2005 Feb;14(2):343-9. doi: 10.1158/1055-9965.EPI-04-0490.
PubMed 15734956Boyd NF, Dite GS, Stone J, Gunasekara A, English DR, McCredie MR, Giles GG, Tritchler D, Chiarelli A, Yaffe MJ, Hopper JL. Heritability of mammographic density, a risk factor for breast cancer. N Engl J Med. 2002 Sep 19;347(12):886-94. doi: 10.1056/NEJMoa013390.
PubMed 12239257Varghese JS, Thompson DJ, Michailidou K, Lindstrom S, Turnbull C, Brown J, Leyland J, Warren RM, Luben RN, Loos RJ, Wareham NJ, Rommens J, Paterson AD, Martin LJ, Vachon CM, Scott CG, Atkinson EJ, Couch FJ, Apicella C, Southey MC, Stone J, Li J, Eriksson L, Czene K, Boyd NF, Hall P, Hopper JL, Tamimi RM; MODE Consortium; Rahman N, Easton DF. Mammographic breast density and breast cancer: evidence of a shared genetic basis. Cancer Res. 2012 Mar 15;72(6):1478-84. doi: 10.1158/0008-5472.CAN-11-3295. Epub 2012 Jan 19.
PubMed 22266113Nazari SS, Mukherjee P. An overview of mammographic density and its association with breast cancer. Breast Cancer. 2018 May;25(3):259-267. doi: 10.1007/s12282-018-0857-5. Epub 2018 Apr 12.
PubMed 29651637Rice MS, Rosner BA, Tamimi RM. Percent mammographic density prediction: development of a model in the nurses' health studies. Cancer Causes Control. 2017 Jul;28(7):677-684. doi: 10.1007/s10552-017-0898-7. Epub 2017 May 6.
PubMed 28478536Yaghjyan L, Colditz GA, Rosner B, Bertrand KA, Tamimi RM. Reproductive factors related to childbearing and mammographic breast density. Breast Cancer Res Treat. 2016 Jul;158(2):351-9. doi: 10.1007/s10549-016-3884-y. Epub 2016 Jun 28.
PubMed 27351801Rice MS, Bertrand KA, Lajous M, Tamimi RM, Torres G, Lopez-Ridaura R, Romieu I. Reproductive and lifestyle risk factors and mammographic density in Mexican women. Ann Epidemiol. 2015 Nov;25(11):868-73. doi: 10.1016/j.annepidem.2015.08.006. Epub 2015 Aug 29.
PubMed 26475982Collaborative Group on Hormonal Factors in Breast Cancer. Breast cancer and breastfeeding: collaborative reanalysis of individual data from 47 epidemiological studies in 30 countries, including 50302 women with breast cancer and 96973 women without the disease. Lancet. 2002 Jul 20;360(9328):187-95. doi: 10.1016/S0140-6736(02)09454-0.
PubMed 12133652Gabrielson M, Chiesa F, Behmer C, Ronnow K, Czene K, Hall P. Association of reproductive history with breast tissue characteristics and receptor status in the normal breast. Breast Cancer Res Treat. 2018 Aug;170(3):487-497. doi: 10.1007/s10549-018-4768-0. Epub 2018 Mar 30.
PubMed 29603032Britt K, Ashworth A, Smalley M. Pregnancy and the risk of breast cancer. Endocr Relat Cancer. 2007 Dec;14(4):907-33. doi: 10.1677/ERC-07-0137.
PubMed 18045947Vashi R, Hooley R, Butler R, Geisel J, Philpotts L. Breast imaging of the pregnant and lactating patient: imaging modalities and pregnancy-associated breast cancer. AJR Am J Roentgenol. 2013 Feb;200(2):321-8. doi: 10.2214/ajr.12.9814.
PubMed 23345353Sabate JM, Clotet M, Torrubia S, Gomez A, Guerrero R, de las Heras P, Lerma E. Radiologic evaluation of breast disorders related to pregnancy and lactation. Radiographics. 2007 Oct;27 Suppl 1:S101-24. doi: 10.1148/rg.27si075505.
PubMed 18180221
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Chilean Maternal and Infant Nutrition Cohort Study II
- ClinicalTrials.gov ID
- NCT03920098
- Acronym / sponsor ID
- CHiMINCs-II / 1190532
- Keywords
- Breast densities, Breast neoplasms, Glucose metabolism disorders, Diabetes, gestational, Pregnancy, Nutritional status, Mental health, Body composition
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,927 participants (actual)
- Lead sponsor
- Instituto de Nutrición y Tecnología de los AlimentosUniversity, hospital or other
- Collaborators
- Pontificia Universidad Catolica de Chile, Servicio de Salud Metropolitano Sur Oriente
- Study start
- 1 Jun 2019 (actual)
- Primary completion
- 30 Jul 2022 (estimated)
- Study completion
- 30 Apr 2023 (estimated)
- First posted
- 18 Apr 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.
The Chilean Maternal \& Infant Cohort Study II (ChiMINCs II) is an ongoing cohort that is part of the Chilean Maternal and Infant Nutrition Observatory of the South-East area of Santiago, Chile. In total, 1927 pregnant women beneficiaries of the public health systems and their offspring were recruited before 12 weeks of gestation and are followed across pregnancy (<15, 26-28, and 35-37 weeks of gestation) and up to 2 years of age of their offspring. Two studies are currently nested in ChiMINCs II: 1) Breast Cancer Risk Assessment in Mothers (BRECAM) study, and 2) the ChiMINCs-COVID study. The primary objective of BRECAM study is to test the association between maternal metabolic indicators (i.e., insulin, glucose, IGF-1, and HbAc1 concentrations) at early pregnancy (i.e., <15 and 26-28 weeks of gestation) and breast density 3 months after the cessation of lactation. For this purpose, we collect maternal obstetric, lifestyle, dietary intake, anthropometric, and biochemical information. The aim of the ChiMINCs-COVID study is to assess dietary-related risks and mental health problems derived from the COVID-19 pandemic and their influence on maternal and infant's health and nutrition. Thus, we collected detailed information on dietary behaviors, mental health and COVID-related information at each trimester, along with neonatal and infant nutritional information. The purpose of the present work is to describe the design, methods, and descriptive information at recruitment of ChiMINCs-II, also discussing the implications that this study can have to better understand maternal and infant nutrition and health during the COVID-19 era.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Mother-infant dyads | – | Other: Nutrition and mental health during pregnancyMother-infant dyads |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- We identified pregnant women who received primary prenatal care within PHCC located in the South East area of Santiago. After, offspring of pregnant women were followed postnatally.
Key inclusion criteria (3 listed)
- 18 or more years of age
- Gestation <15 weeks at first prenatal visit
- No intention to move outside the city of Santiago in the next to years
Key exclusion criteria (3 listed)
- High-risk pregnancy (i.e., preeclampsia, pre- existing diabetes)
- Pre-existing cancer or family history of breast cancer
- Intended to migrate from the public to the private health care system
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 |
|---|---|---|
| Nutrition and mental health during pregnancyAltered metabolic milieu is defined as a fasting glucose level >100 mg/dL at the first trimester of pregnancy by national guidelines. Altered metabolic milieu during the second trimester (24-28 weeks of pregnancy) is defined as a fasting glucose levels > 92 mg/dL and/or plasma glucose levels > 153 mg/dL two hours after load in the oral glucose tolerance test according to ADA guidelines or a fasting glucose >100 mg/dL and/or > 140 mg/dL two hours after load in the oral glucose tolerance test according to national guidelines. The COVID-19 pandemic is considered as a natural nutritional and mental health exposure. | Other | Mother-infant dyads |
Primary outcome
Breast absolute (AFGV) fibro-glandular volume measured by DXA technique
Time frame: Three months after breastfeeding cessation
cm3
Breast absolute percentage (%FVG) of fibro-glandular volume measured by DXA technique
Time frame: Three months after breastfeeding cessation
percentage
Gestational weight gain
Time frame: At delivery
kg
Gestational Diabetes
Time frame: At delivery
Percentage of mothers diagnosed
Pregnancy Risk Assessment Monitoring System
Time frame: Through the gestation, up the delivery
Score
Edinburg Postnatal Depression Scale
Time frame: Through the gestation, up to 6 months
Score
Glucose concentration
Time frame: Through the gestation, up the delivery
mg/dL
Insulin concentration
Time frame: Through the gestation, up the delivery
uIU/mL
Pandemic Anxiety Scale
Time frame: Through the gestation, up the delivery
Score
4 secondary outcomes
Offspring weight
Time frame: At 6 months of age
Offspring length
Time frame: At 6 months of age
Offspring head circumference
Time frame: At 6 months of age
Offspring body fat
Time frame: At 6 months of age
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2022.
- Background: PubMed 16775176McCormack VA, dos Santos Silva I. Breast density and parenchymal patterns as markers of breast cancer risk: a meta-analysis. Cancer Epidemiol Biomarkers Prev. 2006 Jun;15(6):1159-69. doi: 10.1158/1055-9965.EPI-06-0034.
- Background: PubMed 17229950Boyd NF, Guo H, Martin LJ, Sun L, Stone J, Fishell E, Jong RA, Hislop G, Chiarelli A, Minkin S, Yaffe MJ. Mammographic density and the risk and detection of breast cancer. N Engl J Med. 2007 Jan 18;356(3):227-36. doi: 10.1056/NEJMoa062790.
- Background: PubMed 29514672Boyd N, Berman H, Zhu J, Martin LJ, Yaffe MJ, Chavez S, Stanisz G, Hislop G, Chiarelli AM, Minkin S, Paterson AD. The origins of breast cancer associated with mammographic density: a testable biological hypothesis. Breast Cancer Res. 2018 Mar 7;20(1):17. doi: 10.1186/s13058-018-0941-y.
- Background: PubMed 15734956Li T, Sun L, Miller N, Nicklee T, Woo J, Hulse-Smith L, Tsao MS, Khokha R, Martin L, Boyd N. The association of measured breast tissue characteristics with mammographic density and other risk factors for breast cancer. Cancer Epidemiol Biomarkers Prev. 2005 Feb;14(2):343-9. doi: 10.1158/1055-9965.EPI-04-0490.
- Background: PubMed 12239257Boyd NF, Dite GS, Stone J, Gunasekara A, English DR, McCredie MR, Giles GG, Tritchler D, Chiarelli A, Yaffe MJ, Hopper JL. Heritability of mammographic density, a risk factor for breast cancer. N Engl J Med. 2002 Sep 19;347(12):886-94. doi: 10.1056/NEJMoa013390.
- Background: PubMed 22266113Varghese JS, Thompson DJ, Michailidou K, Lindstrom S, Turnbull C, Brown J, Leyland J, Warren RM, Luben RN, Loos RJ, Wareham NJ, Rommens J, Paterson AD, Martin LJ, Vachon CM, Scott CG, Atkinson EJ, Couch FJ, Apicella C, Southey MC, Stone J, Li J, Eriksson L, Czene K, Boyd NF, Hall P, Hopper JL, Tamimi RM; MODE Consortium; Rahman N, Easton DF. Mammographic breast density and breast cancer: evidence of a shared genetic basis. Cancer Res. 2012 Mar 15;72(6):1478-84. doi: 10.1158/0008-5472.CAN-11-3295. Epub 2012 Jan 19.
- Background: PubMed 29651637Nazari SS, Mukherjee P. An overview of mammographic density and its association with breast cancer. Breast Cancer. 2018 May;25(3):259-267. doi: 10.1007/s12282-018-0857-5. Epub 2018 Apr 12.
- Background: PubMed 28478536Rice MS, Rosner BA, Tamimi RM. Percent mammographic density prediction: development of a model in the nurses' health studies. Cancer Causes Control. 2017 Jul;28(7):677-684. doi: 10.1007/s10552-017-0898-7. Epub 2017 May 6.
- Background: PubMed 27351801Yaghjyan L, Colditz GA, Rosner B, Bertrand KA, Tamimi RM. Reproductive factors related to childbearing and mammographic breast density. Breast Cancer Res Treat. 2016 Jul;158(2):351-9. doi: 10.1007/s10549-016-3884-y. Epub 2016 Jun 28.
- Background: PubMed 26475982Rice MS, Bertrand KA, Lajous M, Tamimi RM, Torres G, Lopez-Ridaura R, Romieu I. Reproductive and lifestyle risk factors and mammographic density in Mexican women. Ann Epidemiol. 2015 Nov;25(11):868-73. doi: 10.1016/j.annepidem.2015.08.006. Epub 2015 Aug 29.
- Background: PubMed 12133652Collaborative Group on Hormonal Factors in Breast Cancer. Breast cancer and breastfeeding: collaborative reanalysis of individual data from 47 epidemiological studies in 30 countries, including 50302 women with breast cancer and 96973 women without the disease. Lancet. 2002 Jul 20;360(9328):187-95. doi: 10.1016/S0140-6736(02)09454-0.
- Background: PubMed 29603032Gabrielson M, Chiesa F, Behmer C, Ronnow K, Czene K, Hall P. Association of reproductive history with breast tissue characteristics and receptor status in the normal breast. Breast Cancer Res Treat. 2018 Aug;170(3):487-497. doi: 10.1007/s10549-018-4768-0. Epub 2018 Mar 30.
- Individual participant dataSharing planned: No. Data and blood samples that will be collected in this study will be under the custody of the principal investigator and a human subject protection review board will regulate its use. Others researchers may access the data by contacting to María Luisa Garmendia (Principal Investigator).
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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.
María L Garmendia, PhD principal investigator
Instituto de Nutrición y Tecnología de Alimentos
Camila L Corvalán Aguilar, PhD principal investigator
Institute of Nutrition and Food Technology (INTA), University of Chile, Chile
María F Mujica Coopman, PhD principal investigator
Institute of Nutrition and Food Technology (INTA), University of Chile, Chile
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Density and Body Composition, run by Instituto de Nutrición y Tecnología de los Alimentos at 1 site in Chile.
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 3 inclusion and 3 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 7 Feb 2022. 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 Chile. 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?
Breast absolute (AFGV) fibro-glandular volume measured by DXA technique (time frame: Three months after breastfeeding cessation). The study lists 9 primary outcomes in all. 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 NCT03920098, which also lists 23 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 7 Feb 2022.