Perioperative Iron for Colorectal Cancer (PICoC Study) (NCT05177484) | Clinical Trial Compass
CompletedPhase 3
Perioperative Iron for Colorectal Cancer (PICoC Study)
United Kingdom40 participantsStarted 2022-05-30
Plain-language summary
The PICoC study aims to investigate whether oral ferric maltol given postoperatively offers an improvement in patient and clinician reported outcomes compared to standard care.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Participant is willing and able to give informed consent for participation in the study.
* Male or Female, aged 18+ years.
* Diagnosed with histologically or radiologically diagnosed colorectal adenocarcinoma.
* Anaemic at point of diagnosis of colorectal adenocarcinoma (Defined as haemoglobin 10g/L below WHO criteria: 120g/L for males and 110g/L for females, to account for a 10% fluctuation in Hb)
* Undergoing surgery for colorectal cancer with curative intent.
* Date of planned surgery is ≥ 14 days from date of planned initiation of recruitment.
* Able (in the investigators opinion) and willing to comply with all study requirements.
* Willing to allow his or her General Practitioner and consultant, if appropriate, to be notified of participation in the study.
Exclusion Criteria:
* Patients who do not have a histological diagnosis of colorectal adenocarcinoma
* Female participants who are pregnant, lactating or planning a pregnancy during the course of the study.
* Patients with evidence of iron overload or disturbances in utilisation of iron as stated in the product SPC.
* Previous gastric, small bowel or colorectal surgery (where ≥50% of stomach or terminal ileum has been resected)
* Chemotherapeutic treatment within the last 4 weeks.
* Known previous anaemia not attributable to colorectal carcinoma (i.e. anaemia in patients with well established, inflammatory disorders)
* Known haematological disease.
* Features necessitating urgent surgery (e.g. …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
The Feasibility of Running the Study, to See if it Could be Run as a Large Multi-centre Study
Timeframe: 1 year
Trial details
NCT IDNCT05177484
SponsorThe Royal Wolverhampton Hospitals NHS Trust