Colorectal CancerNCT05891730
Examination of Trends in Colorectal Cancer Patients' Clinical Study Experiences
An observational study of Colorectal Cancer, run by Power Life Sciences Inc. at 1 site in United States.
Trial summary
Clinical study participation percentages haven't always been fully representative of a given demographic. Participation in this observational clinical research is extremely valuable since it allows people with colorectal cancer to contribute their own experiences and unique viewpoints. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer
- How many people
- 500 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2024to Jun 2024
- 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: Colorectal cancer patients who are actively considering involvement in an observational clinical study, but have not yet completed enrollment and registration.
Who may be able to join
- Participant has a diagnosis of colorectal cancer
- Patient has self-identified as planning to enroll in a clinical trial for colorectal cancer
- Patient is at least 18 years of age
Who cannot join
- Inability to perform regular electronic reporting
- Any mental or medical condition that prevents the patient from giving informed consent or participating in the trial
- Pregnant or lactating woman
Trial locations and contacts
1 site in 1 country.
United States1 site
Power Life Sciences
San Francisco, California, 94107
Michael B Gill, 415-900-4227, https://www.withpower.com/contact-us@withpower.com
About this study
Official title: A Detailed Exploration of The Perspectives and Experiences of Patients in Colorectal Cancer Clinical Trials
Clinical study participation percentages haven't always been fully representative of a given demographic.
Participation in this observational clinical research is extremely valuable since it allows people with colorectal cancer to contribute their own experiences and unique viewpoints.
These vital contributions have the potential to affect the development of novel therapies and support services dramatically.
Trial's findings will be critical in furthering the understanding of colorectal cancer, ultimately leading to better patient outcomes.
- Conditions
- Colorectal Cancer
- Keywords
- colorectal cancer
- Medical subject headings
- Colorectal Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of patients who decide to enroll in a colorectal cancer clinical study.
Measured: 3 months
Number of colorectal cancer patients who remain in clinical trial until 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 posted7 Jun 2023
- Study startJun 2024 (estimated)
- Primary completionJun 2024 (estimated)
- Study completionJun 2024 (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 Colorectal 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
- NCT05891730
- Sponsor's protocol ID
- 82251637
- Status last verified
- May 2023
- First submitted
- 26 May 2023
- Last updated
- 7 Jun 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Winkels RM, Heine-Broring RC, van Zutphen M, van Harten-Gerritsen S, Kok DE, van Duijnhoven FJ, Kampman E. The COLON study: Colorectal cancer: Longitudinal, Observational study on Nutritional and lifestyle factors that may influence colorectal tumour recurrence, survival and quality of life. BMC Cancer. 2014 May 27;14:374. doi: 10.1186/1471-2407-14-374.
PubMed 24886284Veettil SK, Wong TY, Loo YS, Playdon MC, Lai NM, Giovannucci EL, Chaiyakunapruk N. Role of Diet in Colorectal Cancer Incidence: Umbrella Review of Meta-analyses of Prospective Observational Studies. JAMA Netw Open. 2021 Feb 1;4(2):e2037341. doi: 10.1001/jamanetworkopen.2020.37341.
PubMed 33591366Njor SH, Andersen B, Friis-Hansen L, de Haas N, Linnemann D, Norgaard H, Roikjaer O, Sondergaard B, Rasmussen M. The optimal cut-off value in fit-based colorectal cancer screening: An observational study. Cancer Med. 2021 Mar;10(5):1872-1879. doi: 10.1002/cam4.3761. Epub 2021 Feb 3.
PubMed 33534955
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Detailed Exploration of The Perspectives and Experiences of Patients in Colorectal Cancer Clinical Trials
- ClinicalTrials.gov ID
- NCT05891730
- Acronym / sponsor ID
- 82251637
- Conditions
- Colorectal Cancer
- Keywords
- colorectal cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Power Life Sciences Inc.Industry (pharma, biotech, devices)
- Study start
- Jun 2024 (estimated)
- Primary completion
- Jun 2024 (estimated)
- Study completion
- Jun 2024 (estimated)
- First posted
- 7 Jun 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.
Clinical study participation percentages haven't always been fully representative of a given demographic.
Participation in this observational clinical research is extremely valuable since it allows people with colorectal cancer to contribute their own experiences and unique viewpoints.
These vital contributions have the potential to affect the development of novel therapies and support services dramatically.
Trial's findings will be critical in furthering the understanding of colorectal cancer, ultimately leading to better patient outcomes.
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
- Colorectal cancer patients who are actively considering involvement in an observational clinical study, but have not yet completed enrollment and registration.
Key inclusion criteria (3 listed)
- Participant has a diagnosis of colorectal cancer
- Patient has self-identified as planning to enroll in a clinical trial for colorectal cancer
- Patient is at least 18 years of age
Key exclusion criteria (3 listed)
- Inability to perform regular electronic reporting
- Any mental or medical condition that prevents the patient from giving informed consent or participating in the trial
- Pregnant or lactating woman
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
Rate of patients who decide to enroll in a colorectal cancer clinical study.
Time frame: 3 months
Number of colorectal cancer patients who remain in clinical trial until 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 7 Jun 2023.
- Background: PubMed 24886284Winkels RM, Heine-Broring RC, van Zutphen M, van Harten-Gerritsen S, Kok DE, van Duijnhoven FJ, Kampman E. The COLON study: Colorectal cancer: Longitudinal, Observational study on Nutritional and lifestyle factors that may influence colorectal tumour recurrence, survival and quality of life. BMC Cancer. 2014 May 27;14:374. doi: 10.1186/1471-2407-14-374.
- Background: PubMed 33591366Veettil SK, Wong TY, Loo YS, Playdon MC, Lai NM, Giovannucci EL, Chaiyakunapruk N. Role of Diet in Colorectal Cancer Incidence: Umbrella Review of Meta-analyses of Prospective Observational Studies. JAMA Netw Open. 2021 Feb 1;4(2):e2037341. doi: 10.1001/jamanetworkopen.2020.37341.
- Background: PubMed 33534955Njor SH, Andersen B, Friis-Hansen L, de Haas N, Linnemann D, Norgaard H, Roikjaer O, Sondergaard B, Rasmussen M. The optimal cut-off value in fit-based colorectal cancer screening: An observational study. Cancer Med. 2021 Mar;10(5):1872-1879. doi: 10.1002/cam4.3761. Epub 2021 Feb 3.
- 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.
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 Colorectal Cancer, run by Power Life Sciences Inc. at 1 site in United States.
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 7 Jun 2023. 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 States. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Michael B Gill (415-900-4227, bask@withpower.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of patients who decide to enroll in a colorectal cancer clinical study. (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 NCT05891730, 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 7 Jun 2023.