Colorectal CancerNCT05356585
Circulating Tumor DNA to Monitor the Efficacy of Total Neoadjuvant Therapy for Rectal Cancer
An observational study of Colorectal Cancer and Rectal Cancer, run by Case Comprehensive Cancer Center at 1 site in United States.
Trial summary
The purpose of this study is to use the SignateraTm assay created from rectal tumor biopsies to monitor participants' blood for fragments of DNA shed by tumor cells. The tumor DNA fragments are referred to as circulating tumor DNA, or ctDNA for short. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer, Rectal Cancer
- What is being tested?
- SignateraTM assay
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Dec 2023to 30 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: Participants will consist of individuals of any gender who are 18 years of age or older. They will all have a diagnosis of stage II or III rectal adenocarcinoma or adenoma.
Who may be able to join
- Newly histologically documented rectal adenocarcinoma or biopsy-proven adenoma with MRI rectum and CT chest/abdomen or PET/CT imaging consistent with stage II or III disease
- Plan is for participant to undergo standard TNT with induction chemoradiation
- Age ≥ 18 years of age
Who cannot join
- Stage I, recurrent, or metastatic rectal cancer
- Received prior therapy for this rectal cancer
- No baseline tumor biopsies with adenocarcinoma or adequate amount of tissue from biopsies available to send for SignateraTM assay development
Trial locations and contacts
1 site in 1 country.
United States1 site
Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
Cleveland, Ohio, 44195
About this study
The purpose of this study is to use the SignateraTm assay created from rectal tumor biopsies to monitor participants' blood for fragments of DNA shed by tumor cells. The tumor DNA fragments are referred to as circulating tumor DNA, or ctDNA for short.
Read the detailed description
Rectal cancer tissue samples that were collected from participants' previous biopsies will be sent to Natera for Signatera assay creation after enrollment onto the study.
One 6 mL tube of blood will be obtained at baseline prior to initiation of treatment. Blood will also be obtained in two 6 tubes at the following points: 3-4 weeks into chemoradiation therapy (CRT), after CRT, after chemotherapy, after surgery for those who undergo resection, and during surveillance 3 months after surgery or at the end of treatment for one year after completion of TNT (total neoadjuvant therapy).
The primary objective of the study is to estimate the percentage of patients with positive ctDNA at the end of TNT .
The secondary objectives of the study include:
- Estimating the change in ctDNA after chemoradiation and chemotherapy
- Characterize the correlation of complete response to TNT with presence or absence of ctDNA
- Describe the recurrence rate in participants with and without ctDNA after TNT
- Characterize the correlation of ctDNA at end of TNT with recurrence free survival at 2 years.
- Conditions
- Colorectal Cancer, Rectal Cancer
- Being tested
- SignateraTM assay
- Keywords
- total neoadjuvant treatment, tumor-specific assay, Circulating Tumor DNA, ctDNA
- Medical subject headings
- Colorectal Neoplasms, Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SignateraTM assayGenetic
A customized tumor-informed ctDNA test that, after receiving the tumor tissue, examines whole exome sequencing of a biopsied tumor to find the somatic tumor-derived mutations. From those mutations, the 16 most clonal mutations are used to create a personal assay
What is being measured
The primary outcome is the main question the study is designed to answer.
Detectable ctDNA at the Completion of TNT
The percentage of participants with detectable ctDNA at the completion of TNT
Measured: up to 24 months after TNT
Secondary outcomes (2)
Change in ctDNA
The change in ctDNA (continuous and categorical positive/negative) during and at the end of neoadjuvant chemoradiation and with chemotherapy will be measured. Continuous measurements will be summarized using medians and ranges. Categorical factors will be summarized using frequencies and percentages. Changes in ctDNA will be analyzed by using the Mann-Whitney U test or the Fisher's exact test for continuous or categorical variables, respectively.
Measured: up to 24 months after TNT
Correlation of Complete Response TNT
Correlation of complete response to TNT defined by presence or absence of ctDNA.
Measured: Up to 24 months after TNT
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2022
- Study start30 Dec 2023 (estimated)
- Primary completion30 Jun 2024 (estimated)
- Study completion30 Jun 2024 (estimated)
Why it stopped: Sponsor already published research that was to be obtained from this study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- More trials run by Case Comprehensive Cancer CenterThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Case Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Smitha Krishnamurthi, MD, Principal investigator, Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05356585
- Sponsor's protocol ID
- CASE9221
- Status last verified
- Apr 2024
- First submitted
- 27 Apr 2022
- Last updated
- 12 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Circulating Tumor DNA to Monitor the Efficacy of Total Neoadjuvant Therapy for Rectal Cancer
- ClinicalTrials.gov ID
- NCT05356585
- Acronym / sponsor ID
- CASE9221
- Conditions
- Colorectal Cancer, Rectal Cancer
- Keywords
- total neoadjuvant treatment, tumor-specific assay, Circulating Tumor DNA, ctDNA
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Sponsor already published research that was to be obtained from this study.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Case Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- 30 Dec 2023 (estimated)
- Primary completion
- 30 Jun 2024 (estimated)
- Study completion
- 30 Jun 2024 (estimated)
- First posted
- 2 May 2022 (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 purpose of this study is to use the SignateraTm assay created from rectal tumor biopsies to monitor participants' blood for fragments of DNA shed by tumor cells. The tumor DNA fragments are referred to as circulating tumor DNA, or ctDNA for short.
Detailed description
Rectal cancer tissue samples that were collected from participants' previous biopsies will be sent to Natera for Signatera assay creation after enrollment onto the study.
One 6 mL tube of blood will be obtained at baseline prior to initiation of treatment. Blood will also be obtained in two 6 tubes at the following points: 3-4 weeks into chemoradiation therapy (CRT), after CRT, after chemotherapy, after surgery for those who undergo resection, and during surveillance 3 months after surgery or at the end of treatment for one year after completion of TNT (total neoadjuvant therapy).
The primary objective of the study is to estimate the percentage of patients with positive ctDNA at the end of TNT .
The secondary objectives of the study include:
- Estimating the change in ctDNA after chemoradiation and chemotherapy
- Characterize the correlation of complete response to TNT with presence or absence of ctDNA
- Describe the recurrence rate in participants with and without ctDNA after TNT
- Characterize the correlation of ctDNA at end of TNT with recurrence free survival at 2 years.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants will consist of individuals of any gender who are 18 years of age or older. They will all have a diagnosis of stage II or III rectal adenocarcinoma or adenoma.
Key inclusion criteria (3 listed)
- Newly histologically documented rectal adenocarcinoma or biopsy-proven adenoma with MRI rectum and CT chest/abdomen or PET/CT imaging consistent with stage II or III disease
- Plan is for participant to undergo standard TNT with induction chemoradiation
- Age ≥ 18 years of age
Key exclusion criteria (3 listed)
- Stage I, recurrent, or metastatic rectal cancer
- Received prior therapy for this rectal cancer
- No baseline tumor biopsies with adenocarcinoma or adequate amount of tissue from biopsies available to send for SignateraTM assay development
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SignateraTM assayA customized tumor-informed ctDNA test that, after receiving the tumor tissue, examines whole exome sequencing of a biopsied tumor to find the somatic tumor-derived mutations. From those mutations, the 16 most clonal mutations are used to create a personal assay | Genetic | – |
Primary outcome
Detectable ctDNA at the Completion of TNT
Time frame: up to 24 months after TNT
The percentage of participants with detectable ctDNA at the completion of TNT
2 secondary outcomes
Change in ctDNA
Time frame: up to 24 months after TNT
Correlation of Complete Response TNT
Time frame: Up to 24 months after TNT
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 12 Apr 2024.
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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.
Smitha Krishnamurthi, MD principal investigator
Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
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 and Rectal Cancer, run by Case Comprehensive Cancer Center 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: withdrawn, as of the sponsor's last update on 12 Apr 2024. 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?
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.
What does the primary outcome measure?
Detectable ctDNA at the Completion of TNT (time frame: up to 24 months after TNT). 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 12 Apr 2024.