1.We seek a better understanding of the mechanism of response / non-response to the above treatment in patients with esophageal carcinoma.2.To investigate whether there is a correlation between the CSC percentage and outcome in esophageal cancer…
ID
Source
Brief title
Condition
- Other condition
- Malignant and unspecified neoplasms gastrointestinal NEC
- Gastrointestinal neoplasms malignant and unspecified
Synonym
Health condition
predictie respons (chemo/radiotherapie in relatie tot kankerstamcelonderzoek (CSC) op basis van tumor gerelateerde organoids
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Question 1: Radioresistance; the effective dose 50% (ED50%) of CSCs enriched
subpopulation will be compared with the ED50% esophageal cancer cell lines
(control group).
Question 2: The percentage of CSCs will be analysed for a possible correlation
between for survival, disease-free survival and recurrences (yes vs no).
Secondary outcome
Not applicable
Background summary
The response to radiotherapy with or without chemotherapy in esophageal cancer
patients is relatively low. Therefore a lot of patients are unnecessarily or
inadequately treated with this complex, intensive and toxic treatment. Cancer
stem cells (CSCs) have been shown to be resistant to radio(chemo)therapy and
possibly responsible for the reported relatively low response in other solid
tumors. Untill now little is known of the role that CSCs play in esophageal
cancer patients.
Study objective
1.We seek a better understanding of the mechanism of response / non-response to
the above treatment in patients with esophageal carcinoma.
2.To investigate whether there is a correlation between the CSC percentage and
outcome in esophageal cancer patients.
Study design
1. From fresh tumor material of patients (resction or if necessary biopsy
material), who have not been treated preoperatively with chemotherapy or
radiotherapy CSC enriched sub-populations will be isolated using culturing
technology and flowcytometry. Dosis-response curves of the CSC enriched
subpopulations will be compared with esophageal cancer cell lines.
2. The percentage CSC will be collected in a prospective database and at the
moment of a adequate duration of the follow up, which should be at least two
years after initial treatment, we will analysed a possible correlation between
the percentage of CSCs and treatment result.
Study burden and risks
The risk of providing additional biopsies is not greater than taken a biopsie
for the diagnosis.
The benefit for the group is that we can get more insight into the mechanism of
radiation response. The results may affecting future treatments and eventually
improved the outcome in these patients. Furthermore the CSC yield can be used
as a prognostic and predictive marker. May be it can help in identifying
patients who will or not benefit from the given therapy at an earlier stage.
Hanzeplein 1 BA31
Groningen 9700 RB
NL
Hanzeplein 1 BA31
Groningen 9700 RB
NL
Listed location countries
Age
Inclusion criteria
All patients in whom a curative intended treatment/ esophageal resection can be performed.
All patient who underwent a endoscopic ultrasound (EUS) procedure for staging and had given permission for additional biopsies of the tumor and normal esophageal mucosa.
Patients should participate in the standard protocol for neo-adjuvant or definitive chemoradiotherapy
Exclusion criteria
Patients who are medically unfit for a curative treatment
Patients who are mentally disabled or incapable to give informed consent
Patients with distant disease
Patients with other intercurrent malignancies except in- situ ca.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL29076.042.09 |
| Other | volgt |