Karma Kontrast is a randomised clinical trial conducted at the mammography unit at Södersjukhuset (Stockholm South General Hospital), Sweden, in collaboration with researchers at Karolinska institutet. The trial will study if contrast enhanced mammography can be used to improve mammography screening. Karma Kontrast is anticipated to go on until January 2022 and will enrol 420 participants.
Due to the pandemic situation enrolment is postponed.
Read more about the trial here (in Swedish only).
Analyses are ongoing in the Karisma 2 Biopsy study. Karisma 2 Biopsy is a nested cohort within the Karisma 2 clinical trial on low-dose tamoxifen, conducted during 2017-2019 in Sweden. In all, 96 participants donated breast biopsied before and after treatment with tamoxifen or placebo. Analyses are ongoing and results are expected after the summer.
We have now completed the Karisma 2 randomised clinical trial on low-dose tamoxifen. In all, 1,440 women were included in the Swedish two-centre study, at Södersjukhuset in Stockholm and at Unilabs in Lund.
The results are being analysed and the first paper is expected to be published after the summer 2020.
Karisma-2 is a dose optimisation study using tamoxifen for preventive use. Women were randomised to five arms of tamoxifen or placebo and were treated for six months.
Doctoral student Shadi Azam has recently published two papers investigating mammographic density change using the KARMA cohort.
In a first paper studying the determinants of change, Azam and colleagues conclude that most risk factors for breast cancer are associated with baseline mammographic density. In contrast, only age, BMI and physical activity are determinants of mammographic density change.
In a second paper, Azam et al. suggest that, although mammographic density is a strong risk factor for breast cancer, mammographic density change does not influence breast cancer risk. Furthermore, density change does not seem to influence the association between baseline mammographic density and breast cancer risk.
The papers can be found at:
Determinants of Mammographic Density Change.
Azam S, Sjölander A, Eriksson M, Gabrielson M, Czene K, Hall P.
JNCI Cancer Spectr. 2019 Feb 4;3(1):pkz004. doi: 10.1093/jncics/pkz004. eCollection 2019 Mar.
Mammographic Density Change and Risk of Breast Cancer.
Azam S, Eriksson M, Sjölander A, Hellgren R, Gabrielson M, Czene K, Hall P
J Natl Cancer Inst. 2019 Jul 12. pii: djz149. doi: 10.1093/jnci/djz149.
The last participants have now ended their participation in Karma Crème-1 and the study is officially closed. Analyses are on-going and we are expecting to publish the results during the autumn 2019.
We have now completed the inclusion of 1,440 women in the Karisma-2 double-blinded clinical trial at the breast centre at Södersjukhuset in Stockholm and at Unilabs in Lund.
Karisma-2 is adose optimisation study using tamoxifen for preventive use.Women were randomised to five arms of tamoxifen or placebo and are treated for six months.
Tamoxifen is used by breast cancer patients to lower the risk of a breast cancer recurrence. It has been shown that perfectly healthy women lower their risk of breast cancer by 50% if they use tamoxifen. However, tamoxifen is not used for prevention due severe side effects.
Preliminary results are expected in late autumn 2019.
Around 62,000 Karma participants have recently received emails regarding strategies for breast cancer risk communication. The Karma group aim to collect questionnaire data from the Karma participants on whether they want to know about their individual risk of breast cancer, and if so, how and by whom the risk should be communicated to the women.
– The Karma project is currently developing a model for individual risk prediction, says Professor Per Hall, PI of the Karma study.
– But before we test such a model in real life and in the clinics, we need to have a better understanding of how women perceive risk, and how we best can communicate about risk in a screening setting. What do screening women consider as gains and losses by changing the screening routine, and are the women interested in participating in preventive strategies such as physical activity and dietary consultation, says Per Hall.
The risk communication questionnaire in an international collaboration between researchers in Sweden, the UK and the Netherlands.
– Sweden has always been in the frontline regarding breast cancer screening therefore it is only logical that we are now taking the next step, says Per Hall.
– I am convinced that we will be the first in the world to implement individualised and risk based breast cancer screening.