Rectal CancerNCT05910099
Taking a Look at Patient Experiences In Rectal Cancer Clinical Trials
An observational study of Rectal Cancer, run by Power Life Sciences Inc. at 1 site in United States.
Trial summary
The primary objective of this research study is to explore the barriers encountered by specific demographic groups of rectal cancer patients during the engagement in clinical trials, which historically lack diverse representation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rectal Cancer
- How many people
- 500 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2024to Jul 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: Patients with rectal cancer who are actively participating in a clinical research, but have not yet completed enrollment and randomization.
Who may be able to join
- Confirmed diagnosis of rectal cancer
- Aged ≥ 18 years old and ability to provide written informed consent obtained prior to participation in the study and any related procedures being performed
- No prior treatment for rectal cancer
Who cannot join
- Pregnant or lactating woman
- Inability to provide written informed consent
- Enrolled in another research study
Trial locations and contacts
1 site in 1 country.
United States1 site
Power Life Sciences
San Francisco, California, 94107
About this study
Official title: Investigating Medical Research Trends in Rectal Cancer Clinical Study: Analyzing Factors Impacting Patient Involvement
The primary objective of this research study is to explore the barriers encountered by specific demographic groups of rectal cancer patients during the engagement in clinical trials, which historically lack diverse representation.
By carefully analyzing data from various demographic perspectives, this study aims to uncover patterns that impact the experiences of future rectal cancer patients. Active involvement in this crucial research is of utmost importance, as it can offer unique insights to enhance the participation and completion rates of rectal cancer patients in clinical study.
- Conditions
- Rectal Cancer
- Keywords
- Rectal Cancer
- Medical subject headings
- Rectal Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of rectal cancer patients who decide to participate in a clinical study
Measured: 3 months
Rate of patients who remain in a rectal cancer clinical study to 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 posted18 Jun 2023
- Study startJul 2024 (estimated)
- Primary completionJul 2025 (estimated)
- Study completionJul 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 Rectal 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
- NCT05910099
- Sponsor's protocol ID
- 85996123
- Status last verified
- Jun 2023
- First submitted
- 9 Jun 2023
- Last updated
- 18 Jun 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Alvarez Sarrado E, Giner Segura F, Batista Domenech A, Garcia-Granero Garcia-Fuster A, Frasson M, Rudenko P, Flor Lorente B, Garcia-Granero Ximenez E. Rectal cancer at the peritoneal reflection. Preoperative MRI accuracy and histophatologic correlation. Prospective study. Cir Esp (Engl Ed). 2022 Aug;100(8):488-495. doi: 10.1016/j.cireng.2022.05.019. Epub 2022 May 18.
PubMed 35597413Bregendahl S, Bondeven P, Gronborg TK, Brown G, Laurberg S, Pedersen BG. Training of radiology specialists in local staging of primary rectal cancer on MRI: a prospective intervention study exploring the impact of various educational elements on the interpretive performance. BMJ Open Qual. 2022 Aug;11(3):e001716. doi: 10.1136/bmjoq-2021-001716.
PubMed 35944932Qaderi SM, Dickman PW, de Wilt JHW, Verhoeven RHA. Conditional Survival and Cure of Patients With Colon or Rectal Cancer: A Population-Based Study. J Natl Compr Canc Netw. 2020 Sep;18(9):1230-1237. doi: 10.6004/jnccn.2020.7568.
PubMed 32886900
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating Medical Research Trends in Rectal Cancer Clinical Study: Analyzing Factors Impacting Patient Involvement
- ClinicalTrials.gov ID
- NCT05910099
- Acronym / sponsor ID
- 85996123
- Conditions
- Rectal Cancer
- Keywords
- Rectal Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Power Life Sciences Inc.Industry (pharma, biotech, devices)
- Study start
- Jul 2024 (estimated)
- Primary completion
- Jul 2025 (estimated)
- Study completion
- Jul 2026 (estimated)
- First posted
- 18 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.
The primary objective of this research study is to explore the barriers encountered by specific demographic groups of rectal cancer patients during the engagement in clinical trials, which historically lack diverse representation.
By carefully analyzing data from various demographic perspectives, this study aims to uncover patterns that impact the experiences of future rectal cancer patients. Active involvement in this crucial research is of utmost importance, as it can offer unique insights to enhance the participation and completion rates of rectal cancer patients in clinical study.
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
- Patients with rectal cancer who are actively participating in a clinical research, but have not yet completed enrollment and randomization.
Key inclusion criteria (3 listed)
- Confirmed diagnosis of rectal cancer
- Aged ≥ 18 years old and ability to provide written informed consent obtained prior to participation in the study and any related procedures being performed
- No prior treatment for rectal cancer
Key exclusion criteria (3 listed)
- Pregnant or lactating woman
- Inability to provide written informed consent
- Enrolled in another research study
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 rectal cancer patients who decide to participate in a clinical study
Time frame: 3 months
Rate of patients who remain in a rectal cancer clinical study to 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 18 Jun 2023.
- Background: PubMed 35597413Alvarez Sarrado E, Giner Segura F, Batista Domenech A, Garcia-Granero Garcia-Fuster A, Frasson M, Rudenko P, Flor Lorente B, Garcia-Granero Ximenez E. Rectal cancer at the peritoneal reflection. Preoperative MRI accuracy and histophatologic correlation. Prospective study. Cir Esp (Engl Ed). 2022 Aug;100(8):488-495. doi: 10.1016/j.cireng.2022.05.019. Epub 2022 May 18.
- Background: PubMed 35944932Bregendahl S, Bondeven P, Gronborg TK, Brown G, Laurberg S, Pedersen BG. Training of radiology specialists in local staging of primary rectal cancer on MRI: a prospective intervention study exploring the impact of various educational elements on the interpretive performance. BMJ Open Qual. 2022 Aug;11(3):e001716. doi: 10.1136/bmjoq-2021-001716.
- Background: PubMed 32886900Qaderi SM, Dickman PW, de Wilt JHW, Verhoeven RHA. Conditional Survival and Cure of Patients With Colon or Rectal Cancer: A Population-Based Study. J Natl Compr Canc Netw. 2020 Sep;18(9):1230-1237. doi: 10.6004/jnccn.2020.7568.
- 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 Rectal 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 18 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 (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 rectal cancer patients who decide to participate in a 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 NCT05910099, 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 18 Jun 2023.