Rectal CancerNCT00835055
Expression of Molecular Markers Before and After Neo-adjuvant Chemoradiotherapy in Rectal Cancer
An observational study of Rectal Cancer, run by St. Claraspital AG at 1 site in Switzerland.
Trial summary
The purpose of this study is to determine whether markers on tumor tissue may be an indicator for good response to neoadjuvant chemoradiotherapy in patients with rectal cancer. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Rectal Cancer
- How many people
- 0 participants
- Where
- 1 siteSwitzerland
- Study dates
- Apr 2005to 1 Apr 2019
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: group is selected from a single institution ( community hospital)
Who may be able to join
- locally advanced rectal cancer uT3 or uT4
- no distant metastasis
- neoadjuvant radiochemotherapy required
Who cannot join
- rejection of radiochemotherapy
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to determine whether markers on tumor tissue may be an indicator for good response to neoadjuvant chemoradiotherapy in patients with rectal cancer.
- Conditions
- Rectal Cancer
- Keywords
- rectal cancer with neoadjuvant treatment, standardized clinical tests, tumor markers on tumor tissue
- Medical subject headings
- Rectal Neoplasms
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2009 (estimated)
- Study startApr 2005
- Primary completion1 Apr 2019
- Study completion1 Apr 2019
Why it stopped: never started several reasons
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rectal 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Claraspital AG
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Beatrice Kern, St. Claraspital AG
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00835055
- Sponsor's protocol ID
- 43/05
- Status last verified
- Apr 2019
- First submitted
- 2 Feb 2009
- Last updated
- 5 Apr 2019
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Expression of Molecular Markers Before and After Neo-adjuvant Chemoradiotherapy in Rectal Cancer
- ClinicalTrials.gov ID
- NCT00835055
- Acronym / sponsor ID
- 43/05
- Conditions
- Rectal Cancer
- Keywords
- rectal cancer with neoadjuvant treatment, standardized clinical tests, tumor markers on tumor tissue
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: never started several reasons
- Enrolment
- 0 participants (actual)
- Lead sponsor
- St. Claraspital AGUniversity, hospital or other
- Study start
- Apr 2005 (actual)
- Primary completion
- 1 Apr 2019 (actual)
- Study completion
- 1 Apr 2019 (actual)
- First posted
- 3 Feb 2009 (estimated)
- 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 purpose of this study is to determine whether markers on tumor tissue may be an indicator for good response to neoadjuvant chemoradiotherapy in patients with rectal cancer.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- group is selected from a single institution ( community hospital)
Key inclusion criteria (3 listed)
- locally advanced rectal cancer uT3 or uT4
- no distant metastasis
- neoadjuvant radiochemotherapy required
Key exclusion criteria (1 listed)
- rejection of radiochemotherapy
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
Not reported in the source record.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2019.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 St. Claraspital AG at 1 site in Switzerland.
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 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: withdrawn, as of the sponsor's last update on 5 Apr 2019. 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 Switzerland. 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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
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 Apr 2019.