Colon CancerNCT05715905
Analyzing Clinical Trial Experiences of Colon Cancer Patients
An observational study of Colon Cancer and Colon Disease, run by Power Life Sciences Inc..
Trial summary
Participation in medical trials usually favors a particular demographic group. But there is limited research available to explain what trial attributes affect the completion of these specific demographic groups. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colon Cancer, Colon Disease
- How many people
- 500 participants
- Where
- No sites listed yet
- Study dates
- Feb 2024to Feb 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
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: Colon cancer patients who are actively considering participating in a clinical trial, but have not yet completed enrollment and randomization.
Who may be able to join
- Patient has been diagnosed with colon cancer
- Patient has self-identified as planning to enroll in an observational clinical trial
- Patient is a minimum of 18 years or older
Who cannot join
- Pregnant or nursing patients
- Inability to perform regular electronic reporting
- Patient does not understand, sign, and return consent form
Trial locations and contacts
No sites are listed yet.
About this study
Official title: An In Depth Study Evaluating Patterns in the Colon Cancer Patients Clinical Trials
Participation in medical trials usually favors a particular demographic group. But there is limited research available to explain what trial attributes affect the completion of these specific demographic groups.
This trial will admit a wide range of data on the clinical trial experience of Colon Cancer patients to determine which factors prevail in limiting a patient's ability to join or finish a trial.
It will also try to analyze data from the perspective of different demographic groups to check for recurring trends which might yield insights for the sake of future Colon Cancer patients.
- Conditions
- Colon Cancer, Colon Disease
- Keywords
- Colon Cancer, Colon Disease
- Medical subject headings
- Colonic Neoplasms, Colonic Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of colon cancer patients who decide to enroll in a clinical trial
Measured: 3 months
Rate of patients who remain in a colon cancer clinical trial to trial completion
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2023
- Study startFeb 2024 (estimated)
- Primary completionFeb 2025 (estimated)
- Study completionFeb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Colon CancerStudies of the same condition, open and under way.
- More trials run by Power Life Sciences Inc.The sponsor's other registered studies.
- 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
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Power Life Sciences Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michael B Gill, Study director, Power Life Sciences Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05715905
- Sponsor's protocol ID
- 81122503
- Status last verified
- Jun 2023
- First submitted
- 27 Jan 2023
- Last updated
- 12 Jun 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Labianca R, Beretta GD, Kildani B, Milesi L, Merlin F, Mosconi S, Pessi MA, Prochilo T, Quadri A, Gatta G, de Braud F, Wils J. Colon cancer. Crit Rev Oncol Hematol. 2010 May;74(2):106-33. doi: 10.1016/j.critrevonc.2010.01.010.
PubMed 20138539Mody K, Bekaii-Saab T. Clinical Trials and Progress in Metastatic Colon Cancer. Surg Oncol Clin N Am. 2018 Apr;27(2):349-365. doi: 10.1016/j.soc.2017.11.008.
PubMed 29496094Iqbal A, George TJ. Randomized Clinical Trials in Colon and Rectal Cancer. Surg Oncol Clin N Am. 2017 Oct;26(4):689-704. doi: 10.1016/j.soc.2017.05.008. Epub 2017 Aug 18.
PubMed 28923225
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An In Depth Study Evaluating Patterns in the Colon Cancer Patients Clinical Trials
- ClinicalTrials.gov ID
- NCT05715905
- Acronym / sponsor ID
- 81122503
- Conditions
- Colon Cancer, Colon Disease
- Keywords
- Colon Cancer, Colon Disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Power Life Sciences Inc.Industry (pharma, biotech, devices)
- Study start
- Feb 2024 (estimated)
- Primary completion
- Feb 2025 (estimated)
- Study completion
- Feb 2026 (estimated)
- First posted
- 8 Feb 2023 (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.
Participation in medical trials usually favors a particular demographic group. But there is limited research available to explain what trial attributes affect the completion of these specific demographic groups.
This trial will admit a wide range of data on the clinical trial experience of Colon Cancer patients to determine which factors prevail in limiting a patient's ability to join or finish a trial.
It will also try to analyze data from the perspective of different demographic groups to check for recurring trends which might yield insights for the sake of future Colon Cancer patients.
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Colon cancer patients who are actively considering participating in a clinical trial, but have not yet completed enrollment and randomization.
Key inclusion criteria (3 listed)
- Patient has been diagnosed with colon cancer
- Patient has self-identified as planning to enroll in an observational clinical trial
- Patient is a minimum of 18 years or older
Key exclusion criteria (3 listed)
- Pregnant or nursing patients
- Inability to perform regular electronic reporting
- Patient does not understand, sign, and return consent form
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
Number of colon cancer patients who decide to enroll in a clinical trial
Time frame: 3 months
Rate of patients who remain in a colon cancer clinical trial to trial completion
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2023.
- Background: PubMed 20138539Labianca R, Beretta GD, Kildani B, Milesi L, Merlin F, Mosconi S, Pessi MA, Prochilo T, Quadri A, Gatta G, de Braud F, Wils J. Colon cancer. Crit Rev Oncol Hematol. 2010 May;74(2):106-33. doi: 10.1016/j.critrevonc.2010.01.010.
- Background: PubMed 29496094Mody K, Bekaii-Saab T. Clinical Trials and Progress in Metastatic Colon Cancer. Surg Oncol Clin N Am. 2018 Apr;27(2):349-365. doi: 10.1016/j.soc.2017.11.008.
- Background: PubMed 28923225Iqbal A, George TJ. Randomized Clinical Trials in Colon and Rectal Cancer. Surg Oncol Clin N Am. 2017 Oct;26(4):689-704. doi: 10.1016/j.soc.2017.05.008. Epub 2017 Aug 18.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
Michael B Gill study director
Power Life Sciences Inc.
Questions about this trial
What is this clinical trial studying?
An observational study of Colon Cancer and Colon Disease, run by Power Life Sciences Inc..
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 3 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 12 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Michael B Gill (4159004227, bask@withpower.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of colon cancer patients who decide to enroll in a clinical trial (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05715905, which also lists 3 linked publications.
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 12 Jun 2023.