Colorectal Cancer Clinical Trial
Official title:
Cohort Study to Evaluate the Relapse Risk Test in Colorectal Cancer
Verified date | March 2023 |
Source | HBI Solutions Inc. |
Contact | James Schilling |
Phone | 6504279198 |
admin[@]mprobe.com | |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
A Retrospective Cohort Study to Evaluate a Multigene assay to assess the recurrence risk of colorectal cancer.
Status | Not yet recruiting |
Enrollment | 1000 |
Est. completion date | December 31, 2024 |
Est. primary completion date | December 31, 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 20 Years and older |
Eligibility | Cohort A Inclusion Criteria: - Subjects must be 20 years of age or older. - Subjects was diagnosed with anatomic stage II, T3, MMR-P colorectal cancer - Subjects had recurrence date information within 5 years follow-up after initial tumor resection surgery - Subject is able and willing to provide FFPE sample per protocol - Subject is able to comprehend and willing to sign and date the written informed consent document(s) and any applicable medical record release documents for the study Exclusion Criteria: - No tumor block available from initial diagnosis before any chemotherapy treatment - Presence of synchronous tumors - No tumor or very little tumor (<5% tumor present) in block as assessed designated pathologist. - Tumor types other than adenocarcinoma NOS (not otherwise specified) and mucinous carcinoma as assessed by examination of the H&E slide by designated pathologist. - Insufficient RNA (<5 ng/µL or 300 ng) for RT-PCR analysis. - Failure of assay to meet pre-specified quality control (QC) specifications. Cohort B Inclusion Criteria: - Subjects must be 20 years of age or older. - Subjects was diagnosed with anatomic stage II, T3, MMR-P colorectal cancer - Subjects had 5 years follow-up information after initial tumor resection surgery - Subject is able and willing to provide FFPE sample per protocol - Subject is able to comprehend and willing to sign and date the written informed consent document(s) and any applicable medical record release documents for the study Exclusion Criteria: - No tumor block available from initial diagnosis before any chemotherapy treatment - Presence of synchronous tumors - No tumor or very little tumor (<5% tumor present) in block as assessed designated pathologist. - Tumor types other than adenocarcinoma NOS (not otherwise specified) and mucinous carcinoma as assessed by examination of the H&E slide by designated pathologist. - Insufficient RNA (<5 ng/µL or 300 ng) for RT-PCR analysis. - Failure of assay to meet pre-specified quality control (QC) specifications. Cohort C Inclusion Criteria: - Subjects must be 20 years of age or older. - Subjects was diagnosed with anatomic stage III A/B colorectal cancer - Subjects had recurrence date information within 5 years follow-up after initial tumor resection surgery - Subject is able and willing to provide FFPE sample per protocol - Subject is able to comprehend and willing to sign and date the written informed consent document(s) and any applicable medical record release documents for the study Exclusion Criteria: - No tumor block available from initial diagnosis before any chemotherapy treatment - Presence of synchronous tumors - No tumor or very little tumor (<5% tumor present) in block as assessed designated pathologist. - Tumor types other than adenocarcinoma NOS (not otherwise specified) and mucinous carcinoma as assessed by examination of the H&E slide by designated pathologist. - Insufficient RNA (<5 ng/µL or 300 ng) for RT-PCR analysis. - Failure of assay to meet pre-specified quality control (QC) specifications. Cohort D Inclusion Criteria: - Subjects must be 20 years of age or older. - Subjects was diagnosed with anatomic stage III A/B colorectal cancer - Subjects had 5 years follow-up information after initial tumor resection surgery - Subject is able and willing to provide FFPE sample per protocol - Subject is able to comprehend and willing to sign and date the written informed consent document(s) and any applicable medical record release documents for the study Exclusion Criteria: - No tumor block available from initial diagnosis before any chemotherapy treatment - Presence of synchronous tumors - No tumor or very little tumor (<5% tumor present) in block as assessed designated pathologist. - Tumor types other than adenocarcinoma NOS (not otherwise specified) and mucinous carcinoma as assessed by examination of the H&E slide by designated pathologist. - Insufficient RNA (<5 ng/µL or 300 ng) for RT-PCR analysis. - Failure of assay to meet pre-specified quality control (QC) specifications. |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
HBI Solutions Inc. | mProbe Inc. |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Recurrence of colorectal cancer | Recurrence of anatomic stage II, MMR-P and stage III A/B colorectal patients | 5 years |
Status | Clinical Trial | Phase | |
---|---|---|---|
Suspended |
NCT05400122 -
Natural Killer (NK) Cells in Combination With Interleukin-2 (IL-2) and Transforming Growth Factor Beta (TGFbeta) Receptor I Inhibitor Vactosertib in Cancer
|
Phase 1 | |
Active, not recruiting |
NCT05551052 -
CRC Detection Reliable Assessment With Blood
|
||
Completed |
NCT00098787 -
Bevacizumab and Oxaliplatin Combined With Irinotecan or Leucovorin and Fluorouracil in Treating Patients With Metastatic or Recurrent Colorectal Cancer
|
Phase 2 | |
Recruiting |
NCT06037954 -
A Study of Mental Health Care in People With Cancer
|
N/A | |
Recruiting |
NCT05425940 -
Study of XL092 + Atezolizumab vs Regorafenib in Subjects With Metastatic Colorectal Cancer
|
Phase 3 | |
Suspended |
NCT04595604 -
Long Term Effect of Trimodal Prehabilitation Compared to ERAS in Colorectal Cancer Surgery.
|
N/A | |
Completed |
NCT03414125 -
Effect of Mailed Invites of Choice of Colonoscopy or FIT vs. Mailed FIT Alone on Colorectal Cancer Screening
|
N/A | |
Completed |
NCT02963831 -
A Study to Investigate ONCOS-102 in Combination With Durvalumab in Subjects With Advanced Peritoneal Malignancies
|
Phase 1/Phase 2 | |
Recruiting |
NCT05489211 -
Study of Dato-Dxd as Monotherapy and in Combination With Anti-cancer Agents in Patients With Advanced Solid Tumours (TROPION-PanTumor03)
|
Phase 2 | |
Terminated |
NCT01847599 -
Educational Intervention to Adherence of Patients Treated by Capecitabine +/- Lapatinib
|
N/A | |
Completed |
NCT05799976 -
Text Message-Based Nudges Prior to Primary Care Visits to Increase Care Gap Closure
|
N/A | |
Recruiting |
NCT03874026 -
Study of Folfiri/Cetuximab in FcGammaRIIIa V/V Stage IV Colorectal Cancer Patients
|
Phase 2 | |
Active, not recruiting |
NCT03170960 -
Study of Cabozantinib in Combination With Atezolizumab to Subjects With Locally Advanced or Metastatic Solid Tumors
|
Phase 1/Phase 2 | |
Completed |
NCT03181334 -
The C-SPAN Coalition: Colorectal Cancer Screening and Patient Navigation
|
N/A | |
Completed |
NCT03167125 -
Participatory Research to Advance Colon Cancer Prevention
|
N/A | |
Recruiting |
NCT04258137 -
Circulating DNA to Improve Outcome of Oncology PatiEnt. A Randomized Study
|
N/A | |
Not yet recruiting |
NCT05775146 -
SBRT of Metastases Following Neo-adjuvant Treatment for Colorectal Cancer With Synchronous Liver Metastases
|
Phase 2 | |
Recruiting |
NCT05568420 -
A Study of the Possible Effects of Medication on Young Onset Colorectal Cancer (YOCRC)
|
||
Recruiting |
NCT02972541 -
Neoadjuvant Chemotherapy Verse Surgery Alone After Stent Placement for Obstructive Colonic Cancer
|
N/A | |
Completed |
NCT02876224 -
Study of Cobimetinib in Combination With Atezolizumab and Bevacizumab in Participants With Gastrointestinal and Other Tumors
|
Phase 1 |