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Sponsor already published research that was to be obtained from this study.
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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.
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:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SignateraTM assay | Genetic | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Detectable ctDNA at the Completion of TNT | The percentage of participants with detectable ctDNA at the completion of TNT | up to 24 months after TNT |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| The recurrence rate (local and distant) with positive ctDNA and negative ctDNA after TNT | The recurrence rate (local and distant) is the number of participants with positive ctDNA and negative ctDNA after TNT for both participants who undergo watch and wait and those who have surgery. Non operative management (watch and wait) is offered to participants who have a complete clinical response who will comply with required surveillance. Outcomes will be recorded and described for all participants, those who underwent surgery and those who underwent non-operative management. |
Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Smitha Krishnamurthi, MD | Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center | Cleveland | Ohio | 44195 | United States |
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| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D012004 | Rectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
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Formalin-fixed, paraffin embedded tissue from the patient's colonoscopy or flexible sigmoidoscopy in surgeon's office will be sent to Natera for Signatera assay creation after enrollment onto the study
Blood will be collected in Ethylenediamine tetraacetic acid (EDTA) tubes and sent to Natera via shipping materials provided by Natera.
| up to 24 months after TNT |
| Correlation of Complete Response TNT | Correlation of complete response to TNT defined by presence or absence of ctDNA. | Up to 24 months after TNT |
| Up to 24 months after TNT |
| The correlation of ctDNA at end of TNT with relapse-free survival | The presence or absence of ctDNA with relapse-free survival.Time to event variable will be summarized using the Kaplan-Meier method. Outcomes will be recorded and described for all patients, those who underwent surgery and those who underwent non-operative management. | After 2 years of surveillance post-TNT |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |