CancerHI-CARENCT07006909
Hair Isotope Analysis for Early Cancer Detection
An observational study of Cancer, run by University of Reading at 1 site in United Kingdom.
Trial summary
Cancer is a major health challenge, and early detection is crucial for improving patient outcomes. Research has shown that cancer can alter the way the body processes nutrients. This study aims to explore whether these metabolic changes can be detected through a simple, non-invasive method: analysing hair. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer
- How many people
- 20 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Sep 2025to 30 May 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Cancer patients in the UK
Who may be able to join
- Cancer diagnosis, sufficient hair
Who cannot join
- -
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Cancer is a major health challenge, and early detection is crucial for improving patient outcomes. Research has shown that cancer can alter the way the body processes nutrients. This study aims to explore whether these metabolic changes can be detected through a simple, non-invasive method: analysing hair. Hair grows slowly over time, potentially capturing subtle metabolic changes that occur during cancer development. By studying the nitrogen stable isotope composition in hair samples donated by individuals diagnosed with cancer, we aim to identify potential early markers of the disease. Participants will be asked to donate a small strand of hair, which will be analysed using a laboratory technique called Isotope Ratio Mass Spectrometry (IRMS). The findings from this study could contribute to new, non-invasive screening tools for early cancer detection.
- Conditions
- Cancer
- Keywords
- cancer, hair, stable isotope ratio
- Medical subject headings
- Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
longitudinal changes in d15N in hair
Longitudinal changes in d15N in hair samples to obtain a time-series
Measured: Approximately one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2025
- Study start1 Sep 2025 (estimated)
- Primary completion30 May 2030 (estimated)
- Study completion30 May 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies 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
- Cross-sectional
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Reading
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gunter G C Kuhnle, University of Reading
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07006909
- Sponsor's protocol ID
- HI-CARE 01
- Acronym
- HI-CARE
- Status last verified
- May 2025
- First submitted
- 27 May 2025
- Last updated
- 5 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Participation will be anonymous
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hair Isotope Analysis for Early Cancer Detection
- ClinicalTrials.gov ID
- NCT07006909
- Acronym / sponsor ID
- HI-CARE / HI-CARE 01
- Conditions
- Cancer
- Keywords
- cancer, hair, stable isotope ratio
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of ReadingUniversity, hospital or other
- Study start
- 1 Sep 2025 (estimated)
- Primary completion
- 30 May 2030 (estimated)
- Study completion
- 30 May 2030 (estimated)
- First posted
- 5 Jun 2025 (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.
Cancer is a major health challenge, and early detection is crucial for improving patient outcomes. Research has shown that cancer can alter the way the body processes nutrients. This study aims to explore whether these metabolic changes can be detected through a simple, non-invasive method: analysing hair. Hair grows slowly over time, potentially capturing subtle metabolic changes that occur during cancer development. By studying the nitrogen stable isotope composition in hair samples donated by individuals diagnosed with cancer, we aim to identify potential early markers of the disease. Participants will be asked to donate a small strand of hair, which will be analysed using a laboratory technique called Isotope Ratio Mass Spectrometry (IRMS). The findings from this study could contribute to new, non-invasive screening tools for early cancer detection.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Cancer patients in the UK
Key inclusion criteria (1 listed)
- Cancer diagnosis, sufficient hair
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
longitudinal changes in d15N in hair
Time frame: Approximately one year
Longitudinal changes in d15N in hair samples to obtain a time-series
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2025.
- Individual participant dataSharing planned: No. Participation will be anonymous
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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.
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 Cancer, run by University of Reading at 1 site in United Kingdom.
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 1 inclusion and 1 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: opening soon, as of the sponsor's last update on 5 Jun 2025. 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 United Kingdom. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Gunter GC Kuhnle, Doctor rerum naturalium (+44 118 3787723, g.g.kuhnle@reading.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
longitudinal changes in d15N in hair (time frame: Approximately one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Jun 2025.