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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2021-08733 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| STUDY00022247 | Other Identifier | OHSU Knight Cancer Institute |
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| Name | Class |
|---|---|
| Natera, Inc. | INDUSTRY |
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This study measures the levels of circulating tumor DNA (ctDNA) in patients with stage II-III rectal cancer before, during, and after treatment to find out if the presence or absence of ctDNA in patient's blood using the Signatera test can be used to gauge how different treatments may affect rectal cancer. ctDNA is DNA from the rectal cancer that is circulating in the blood. The purpose of this study is to understand if the way rectal tumors respond to standard treatment can be associated with varying levels of ctDNA.
PRIMARY OBJECTIVE:
I. To estimate the percentage of participants that achieve complete clinical response.
SECONDARY OBJECTIVES:
I. To assess circulating tumor deoxyribonucleic acid (ctDNA) status among participants receiving total neoadjuvant therapy (TNT).
II. To assess molecular residual disease (MRD i.e., ctDNA status). III. To assess the rate of transabdominal surgery. IV. To assess the rate pathological complete response after surgery. V. To assess the rate of watch and -wait (W&W) after TNT. VI. To assess disease-free survival (DFS). VII. To assess overall survival (OS).
EXPLORATORY OBJECTIVES:
I. To characterize ctDNA clearance or non-clearance patterns during TNT. II. To correlate ctDNA levels with a participant's pathological features. III. To preliminary assess the prognostic performance of ctDNA levels in relation to participant's clinical outcome.
OUTLINE:
Patients undergo collection of blood samples at baseline (before any neoadjuvant therapy), every 2 months while undergoing TNT, and then every 3 months for up to 3 years after completion of TNT. Patients' medical records are also reviewed. Patients may undergo collection of tissue sample if an archival tissue sample is not available.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Observational (biospecimen collection, medical record review) | Patients undergo collection of blood samples at baseline (before any neoadjuvant therapy), every 2 months while undergoing TNT, and then every 3 months for up to 3 years after completion of TNT. Patients' medical records are also reviewed. Patients may undergo collection of tissue sample if an archival tissue sample is not available. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Biopsy | Procedure | Undergo biopsy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Complete clinical response (cCR) | cCR following TNT will be analyzed using the TNT analysis set. Proportions of participants that achieved cCR will be calculated and the exact 95% confidence interval (CI) will be presented. | From time of treatment start up to date of completing total neoadjuvant therapy (TNT), up to 3 months. |
| Measure | Description | Time Frame |
|---|---|---|
| Positive circulating tumor deoxyribonucleic acid (ctDNA) | The proportion of ctDNA positive participants (at baseline, throughout TNT, and follow-up) and its exact 95% CI will be evaluated using the ctDNA analysis set. Where appropriate, sub-analyses will be conducted using populations that underwent surgery or were monitored using a watch and wait (W&W) strategy. | From date of baseline measure of ctDNA (i.e., number of mutant molecules per mL) to date of until the date of first documented progression, up to 3 years. |
| Measure | Description | Time Frame |
|---|---|---|
| ctDNA status | positive versus negative results per test results | From date of baseline measure of ctDNA (i.e., number of mutant molecules per mL) to date of until the date of first documented progression, up to 3 years |
| Positive ctDNA by clinical characteristics |
Inclusion Criteria:
Participant must provide written informed consent before any study-specific procedures or interventions are performed
Participants aged >= 18 years
Pathologically-confirmed stage II or III primary adenocarcinoma of the rectum:
Exclusion Criteria:
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Patients with stage II-III rectal adenocarcinoma at Oregon Health & Science University (OHSU), its affiliated community oncology (CHO) site, or collaborating research site
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| Name | Affiliation | Role |
|---|---|---|
| Adel Kardosh, M.D.,Ph.D. | OHSU Knight Cancer Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| OHSU Knight Cancer Institute | Recruiting | Portland | Oregon | 97239 | United States |
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Blood, tissue
| Biospecimen Collection | Procedure | Undergo collection of blood and/or tissue samples |
|
|
| Electronic Health Record Review | Other | Medical records are reviewed |
|
| Positive ctDNA after completing TNT | The proportion of ctDNA positive participants (at baseline, throughout TNT, and follow-up) and its exact 95% CI will be evaluated using the ctDNA analysis set. Where appropriate, sub-analyses will be conducted using populations that underwent surgery or were monitored using a W&W strategy. | From date of baseline measure of ctDNA (i.e., number of mutant molecules per mL) to date of until the date of first documented progression, up to 3 years |
| Rate of transabdominal surgery | Will be evaluated using the TNT analysis set. The corresponding exact 95% CI will also be presented. | Up to 3 years following completion of TNT |
| Rate of pathological complete response (pCR) | Will be evaluated using the TNT analysis set. The corresponding exact 95% CI will also be presented. | From start of treatment until completion of surgery, up to 3 years. |
| Rate of watch and wait strategy | Will be evaluated using the TNT analysis set. The corresponding exact 95% CI will also be presented. | Up to 3 years following completion of TNT |
| Disease-free survival | Will be estimated using the Kaplan-Meier method. | Time between the date of surgery (or W&W population, the date of completing TNT) and the date of local or metastatic recurrence or death from any cause, assessed up to 3 years following completion of TNT |
| Overall survival | Will be estimated using the Kaplan-Meier method. | Time between the date of signed consent to the date of death from any cause, assessed up to 3 years following completion of TNT |
association or recurrence on ctDNA test and standard imaging |
| From date of baseline measure of ctDNA to date of recurrence or death from any cause, assessed up to 3 years following completion of TNT |
| Sensitivity | Sensitivity and specificity will be calculated using complete clinical response (yes versus [vs.] no), or tumor recurrence (yes vs. no) as reference standard. | From date of baseline measure of ctDNA to date of recurrence or death from any cause, assessed up to 3 years following completion of TNT |
| Specificity | Sensitivity and specificity will be calculated using complete clinical response (yes vs. no), or tumor recurrence (yes vs. no) as reference standard. | From date of baseline measure of ctDNA to date of recurrence or death from any cause, assessed up to 3 years following completion of TNT |
| Fred Hutch | Recruiting | Seattle | Washington | 98109 | United States |
|
| ID | Term |
|---|---|
| D012004 | Rectal Neoplasms |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
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| ID | Term |
|---|---|
| D001706 | Biopsy |
| ID | Term |
|---|---|
| D003581 | Cytodiagnosis |
| D003584 | Cytological Techniques |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D013048 | Specimen Handling |
| D003949 | Diagnostic Techniques, Surgical |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |
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