breast cancer study

[SaltedCaramelHC]

There have been several news articles about a major study into breast cancer detection, and whether a personalised schedule of mammograms is better than the standard protocol for everyone. They are recruiting for participants, and it sounded like it could be a good thing to be involved in.

clinicaltrials.gov/ct2/show/NCT03672331?term=mypebs&rank=1

But. In the description of participants, it lists things like age range: 40-70, and sex : females.

Then under 'inclusion criteria', it again says female (whether born female or not), which surely is incompatible with the study aims, if it's intending to investigate breast cancer detection in women.

if it's intending to investigate breast cancer in both men and women, then they could have specified that in the study description, which only specifies females; if they are going to include males presenting as females, that is a very specific set of circumstances, with its own hormonal profiles and risks, and deserves dedicated research. Nowhere is it indicated whether the results of these participants will be analysed separately, and the fact that the recruitment is just lumped together as 'whether born female or not' doesn't fill me with confidence that it will be (not to mention the lack of confidence in their understanding of 'female' - even for those people who widen the category of 'women', surely 'female' should still have had meaning, at least in medical research!).

Under exclusions, it says 'those with bilateral mastectomy', which rules out some females who may be presenting as males, although again, the risks of breast cancer in this situation sounds like something that deserves dedicated research anyway.

(psychiatric and other disorders also excluded, but for reasons of not being able to comply with the study protocols, which I don't think would apply here).

I think it could be an important and useful study, but it's frustrating to find the information for recruitment misusing terms like female, and it makes me wonder about the way that results will be presented too.

I would expect the authors to follow SAGER guidelines (Sex and Gender Equity in Research) for publication and reporting (I think this is open access and not paywalled). SAGER uses sex and gender in the way that FWR would expect.

Heidari S, Babor TF, De Castro P, Tort S, Curno M. Sex and Gender Equity in Research: rationale for the SAGER guidelines and recommended use. Res Integr Peer Rev. 2016 May 3;1:2. doi: 10.1186/s41073-016-0007-6. PMID: 29451543; PMCID: PMC5793986.

researchintegrityjournal.biomedcentral.com/articles/10.1186/s41073-016-0007-6

I think that transwomen also have mammograms, don't they? Though no idea to what degree they would change the outcomes of a study like this. Maybe not at all since they may be looking a very specific profile outcomes rather than aggregate data?

You'd hope so, wouldn't you.

But if even at the recruiting stage,they are using 'females' to mean anyone who identifies as female, I end up a bit skeptical. I hope that it's just a requirement to say that in the recruitment process, so that they don't get targeted, but that they will be clear when it comes to reporting. It seems an inefficient way to design a study, though, because the proportion of respondents who say that they are female, but were not female at birth, would be fairly small, and would need quite specific protocols for inclusion and participation - so you'd think that there would be better ways of recruiting them if this is in fact what you were wanting to research. On the other hand, if you are not actually wanting to study this population, then it's a waste of resources to have to include them in the inclusion criteria but then not actually be able to use the data collected because it's too small or too diverse a group.

I don't know if transwomen have mammograms - I assume so, but I also imagine that the profile for determining risk would be quite different, so it seems like a confounding factor. Maybe it won't be, if it does separate people into risk categories individually, although I still think that a transwomen deemed 'low risk' and a female deemed 'low risk' would be in those categories for different reasons, and that still needs to be clearly communicated and analysed, if conclusions that change the healthcare on offer are drawn.

Thanks for drawing attention to this study. I thought it sounded interesting so emailed to ask if I could join. Already had a reply! Almost by return, must have just struck lucky.

Anyway, I want to highlight they are only looking for women from Leeds, Manchester and Cambridge, not the rest of the UK. No good for me as a Londoner, sadly.

only looking for women from Leeds, Manchester and Cambridge, not the rest of the UK. No good for me as a Londoner, sadly

There's an eligibility questionnaire on the eu site (still includes the UK) for anyone interested in taking this further and is in the named areas (you can still answer the first question but will be screened out if you're not in those areas).

www.mypebs.eu/take-part-in-mypebs/

oh that's a shame for you. I am in one of the areas, which is probably why I came across the news on several sites. A shame, as it is easy to get to Addenbrookes, at least, from London - less than an hour, and it isn't like it's very many visits!

I am still considering joining. The reason I went into the greater details of the protocols etc on the other linked page as I wanted to know whether those in 'low risk' groups would actually get less frequent scans than the NHS protocol ,or whether they would do both scans at 3 years and scans at 4 years, and then see if the extra year made any difference for low-risk women, before recommending a 4-year interval for people in that category. I don't know what my risk would be; I'm guessing perhaps a bit higher than usual because of weight, not having had children, etc, but then I'm at the younger end of the range, and no family history, so maybe I'd be lower risk after all. And I'm not sure I'd want to take the chance of going to 4 yearly just in case!