Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Participants will a diagnosis of gastroesophageal junction (GEJ) adenocarcinoma and will have either a minimally invasive proximal gastrectomy (MIPG) or a minimally invasive total gastrectomy (MITG) as part of their routine care. Participants with complete a questionnaire 1 month before the surgical procedure and then 1, 3, 6 and 12 months after the surgical procedure.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Minimally Invasive Proximal Gastrectomy/MIPG | Participants will undergo MIPG (Trial Procedure) |
| |
| Minimally Invasive Total Gastrectomy/MITG | Participants will undergo MITG (Standard of Care/Control Group) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MDASI-GI | Other | The MDASI-GI assesses 5 symptoms specific to gastrointestinal cancer: constipation diarrhea or watery stools difficulty swallowing change in taste feeling bloated Using this questionnaire, participants score the severity of their symptoms over the previous 24 hours on a scale of 0 (not present) to 10 (as bad as you can imagine). |
| Measure | Description | Time Frame |
|---|---|---|
| Appetite level score according to the MDASI-GI | The primary outcome is the appetite level score (with 0 being the best and 10 being the worst) according to the MDASi-GI at 3 months after surgery | 3 months after surgery |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
The initial contact with the potential participants will be conducted either by the treatment team, investigator or the research staff working in consultation with the treatment team. Participants will be screened in gastric and mixed tumor surgery clinics on the 5th floor of the MSKCC 53rd Street outpatient clinic building. The investigator/research staff will review portions of the medical record to determine if they are eligible. Participants who are eligible will be approached by study personnel in clinic. The study will be explained to participants by the study personnel and interested participants will be given the consent form to review.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Vivian Strong, MD | Memorial Sloan Kettering Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Memorial Sloan Kettering Basking Ridge (All Protocol Activities) | Basking Ridge | New Jersey | 07920 | United States | ||
Not provided
| Label | URL |
|---|---|
| Memorial Sloan Kettering Cancer Center | View source |
Not provided
Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
|
| Memorial Sloan Kettering Monmouth (All Protocol Activities) |
| Middletown |
| New Jersey |
| 07748 |
| United States |
| Memorial Sloan Kettering Bergen (All protocol activities) | Montvale | New Jersey | 07645 | United States |
| Memorial Sloan Kettering Commack (All Protocol Activities) | Commack | New York | 11725 | United States |
| Memorial Sloan Kettering Westchester (All Protocol Activities) | Harrison | New York | 10604 | United States |
| Memorial Sloan Kettering Cancer Center (All Protocol Activities) | New York | New York | 10065 | United States |
| Memorial Sloan Kettering Nassau (Limited Protocol Activites) | Rockville Centre | New York | 11553 | United States |
| MD Anderson Cancer Center (Data Analysis Only) | Houston | Texas | 77030 | United States |
| ID | Term |
|---|---|
| D013274 | Stomach Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |
Not provided
Not provided