On the trail of a Clinical Trial…

First Published May 9th 2022

3 ½ years ago I was diagnosed with triple positive Inflammatory Breast Cancer, considered incurable due to distant lymph node spread. Reassured (only slightly!) by an oncologist, I was told that there are several treatment lines and then there are clinical trials, so nothing to be despondent about yet. Fast forward and that’s still my understanding now: that clinical trials for *metastatic/stage IV/secondary/advanced breast cancer patients are out there, being easily perused by clinicians and patients alike. An online supermarket of trials to select from. COVID19 put paid to any utopia thinking that there are a plentiful number of trials, but trials there must be. Right?

METUPUK historically maintained their own in-house clinical trial database for metastatic trials in the UK as there was no one source that contained them all. It used the key sites used across the UK; Cancer Research UK, Be Part of Research, ISRCTN and ClinicalTrials.gov (an American hosted site used globally).

Leaping forward to 2022, surely by now one of them must be THE accurate, easily searchable source of breast cancer trials? If not, how do our oncologists quickly and accurately find the best trials for their metastatic patients? And where do patients start when looking for a metastatic trial themselves? Being an IT geek for the last 15 years, I dived in.

Sadly, there is still no one source that contains all of the metastatic trials for breast cancer. There is not one source that can easily be searched to establish that fact. And when I say ‘searched’ I mean just to get metastatic trials, not the fine-grained filtering ability of sub type, number of treatment lines etc. Let that sink in. My manual, old-school comb through of the various sites taking days is what would be needed to find the 82 currently recruiting trials for metastatic breast cancer. And let’s be honest, because manually combining data is the only way, I’m sure to be missing the odd few as well. This is how the results from the big sites shape up to our 82:

Breast Cancer Now – 0. They do not maintain their own searchable registry of breast cancer trials in the UK. Note, in comparison, that the charity Target Ovarian Cancer maintain their own searchable listing on their website, filtered by sub types and curative, recurrence etc for Ovarian Cancer. See footnote (1).

Cancer Research UK – 17. That number only made possible through manually combing through all trials. See footnote (2) below to read the detail on the painful searching.

Be Part of Research – 39. Again, manual intervention needed to weed out any trials that make reference to ‘metastatic’ in body text. No pre-determined filters/categories to aide searching. See footnote (3).

ISRCTN 11. All but 1 were listed on Clinical Trials.Gov. Annoyingly that means I can’t discount it as a source to include. See footnote (4).

Clinical Trials.Gov – 56. The largest source but again blighted by poor searching functionality and tagging of data. On trialing their new beta site, I was able to filter by metastatic breast cancer (yay – finally!) however the total of 54(?) recruiting trials in the UK was muddled with incorrect entries. Examples like the term ‘metastases’ in relation to axillary nodes (stage 3), a study with metastases excluded in the body text rather than patient information section, a trial including ‘non-metastatic…’ in its title – seriously people!! See footnote (5).

Accurate data is of course the Holy Grail of all systems and databases. The importance of language is also part of the problem. By using metastatic/stage IV/secondary/advanced interchangeably within the clinical breast cancer world, it makes for complex search criteria.

It seems that in 2022, we, the patients, the advocates, those dying for a cure, are responsible for finding their own metastatic trial information. What we have ended up with is a Venn diagram where every site has something unique and therefore can’t be discounted.

We have less than 27 ½ years for all breast cancer patients to live (corporate aim from Breast Cancer Now) and yet don’t even know what life-extending trials there are currently available for the 31 women who die every day from MBC. METUPUK is currently reeling from the death of one of our members last week, and the thought that if trial information was easier to access and dissect, Emma might still be here with us today, is one we are struggling to cope with.

Footnotes:

(1) Breast Cancer Now (BCN). Arguably the main charity and champions for breast cancer patients across the UK and who brand themselves as ‘the research and care charity’. Despite funding a number of clinical trials, they don’t maintain a searchable registry themselves but provide re-directs to other trial sites for searching clinical trials. Annoying, yes. Note that the charity Target Ovarian Cancer maintain their own searchable listing on their website, filtered by sub types and curative, recurrence etc . WE NEED THIS!! BCN recommend the NHS website (which doesn’t have a listing as it uses Be Part of Research), Cancer Research UK and Be Part of Research.  I plough on to Cancer Research UK as the first recommendation from BCN.

(2) Cancer Research UK Now this is where the IT techy (and the patient) in me starts to get annoyed. Of the 17 trials on the Cancer Research UK site applicable to metastatic patients that are recruiting, only 2 come up when using a manual search for ‘breast cancer metastatic, 5 come up when searching ‘breast cancer stage 4’ (but only 2 out of the 5 are for metastatic/stage 4/secondary patients). ‘Breast cancer secondary’ retrieves only 6 trials. If we filter by ‘secondary’ and then add the sub filter of ‘breast cancer’ we get 8 results. The only way to get the full list of 17 is when you individually sift through ALL breast cancer search results one by one reading the inclusion/exclusion criteria. Why’s that? Because, I would guess, that the right tagging (metadata for any IT readers) hasn’t been put in for the trial to be picked up in a search. They also like to use the term ‘secondary’ and filter based on where your secondary is. For example, filtering on ‘secondary – spread to the liver’ I get a bowel cancer trial as there is no additional inclusion of the primary filter. I’m sure there are probably more than the 17 (especially for solid tumour trials that include a number of cancers) but frankly who will be reading through every trial inclusion to find out?

Cancer Research UK state “We have a searchable database of cancer trials. We don’t only include Cancer Research UK trials on our database. We aim to include information on all trials and studies that recruit people in the UK, funded by a wide range of organisations.” I think that’s a long way off if it really is an aim. 11 trials were unique to Cancer Research UK that weren’t listed anywhere else.

(3) Be Part of Research Moving swiftly on from those organisations whose role is specifically for cancer, (insert a large eyeroll from me) to the second recommended listing from BCN, Be Part of Research. Perhaps I’ll fair better with this site as it’s what the NHS and Department of Health direct people to.

Medical conditions are listed within each trial listing and look like they are pre-formed information. But on closer inspection they must be free-formed typed as there are many different grammatical variations of the same terms. They also aren’t included in the search/filtering functionality grrrr. 39 metastatic trials are recruiting but very difficult to pull the information together and, like Cancer Research UK, it required manual collations of multiple searches.  Be Part of Research has a significant overlap with the beast that is ClinicalTrials.Gov, however not all of them are listed.

(4) ISRCTN They are piloting a new dashboard to see trials as well but doesn’t do free text search yet so can’t look at just breast cancer trials, for example. I found 11 trials (by combining search results) although these are overlapping with Cancer Research UK’s 17 trials. One unique trial which no other site had meaning I have to keep checking it.

(5) ClinicalTrials.gov Finally onto the big guns. ClinicalTrials.gov is a database of privately and publicly funded clinical studies conducted around the world (note that the website currently being modernised). When trialling the beta version of the new site, I’m specifically able to pick ‘breast cancer metastatic’ as a search term and ‘United Kingdom’ as a location, so far so good. I get only 25 results which obviously means that ‘United Kingdom’ is not a correct way of getting UK trials. Back to the original clunky Clinical Trials. Gov site. A lot of combining data to get the eventual 56.

**EU Clinical trials register – after a cursory 30 mins of varying methods to search I abandoned as it was possibly the least user-friendly site I had dealt with.

**WHO International Clinical Trials Registry Platform aggregates data from ClinicalTrials.gov, EU Clinical Trials Register (EU-CTR) and ISRCTN so wasn’t reviewed. The ‘recruiting’ filter didn’t work as expected either.

kat lee

By MetUpUK Member, Katherine Lee.

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