Prognosis of Signet Ring Cells in Upper Digestive Neoplasms

NCT01249859 | Completed DMC

• 1 other identifier: ADCI 001
• Study Type: observational
• Target: 2,500
• Locations: 1 country
• Sites: 1

Brief Summary

Background • A major increase in incidence of signet ring cell adenocarcinomas (ADCI) of the upper digestive tract in western countries

• Discordant results in the literature concerning the prognosis value of the presence of signet ring cells.
• Preliminary data suggesting (i) an advanced stage at time of diagnosis, (ii) more often in the form of carcinose, (iii) a more pejorative prognosis, (iv) a recurrence more frequent, more quickly, and more often in the form of peritoneal carcinose, (v) a chemo resistance (vi) the need for a specific therapeutic strategy compared to non-signet ring cell adenocarcinomas. Primary objective To test the hypothesis that 5-year survival rate is significantly lower in the signet ring cells (SRC) adenocarcinoma when compared to non-SRC adenocarcinoma in the upper digestive tract Secondary objectives
• Impact of neoadjuvant CT on overall survival
• Impact and differential diagnostic value of linitis
• R0 resection rates
• 3 years recurrence free survival
• Overall 3 years survival
• Prognostic factors
• Prognostic value of the presence of a minority quota of signet ring cell
• Objective response rate after medical treatment (chemotherapy, radiochemotherapy) in non-resected patients
• Tolerance of (radio) chemotherapy for ADCI Methodology Intention to treat retrospective case-control multicentric study A pairing on demographic criteria (age, sex, ASA score, center) and tumor criteria (TNM stage) will be done to ensure comparability in case control study groups. Inclusion criteria All consecutive patients taken care of, for a proven histologically adenocarcinoma (ADCI and ADNCI) of the esophagus, the esogastric junction, or the stomach, in surgical or medical oncology investigator centers, will be saved in a given database. For whom the first consultation took place between January 1997 and January 2010 Exclusion criteria Histological type other than adenocarcinoma Other localization than esogastric junction, esophagus or stomach Planned study period The data will be collected over a period from January 1997 to January 2010. The objective is to complete the data collection for summer 2010.

Conditions

Signet Ring Cell Carcinoma; Stomach Disease; Oesophagus; Prognostic; Case-control Study

Keywords

stomach disease; signet ring cell carcinoma; chemotherapy; Prognostic

Outcome Measures

Primary Outcomes (1)

• To test the hypothesis that 5-year survival rate is significantly lower in the signet ring cells (SRC) adenocarcinoma when compared to non-SRC adenocarcinoma in the upper digestive tract

  participants are followed until death or time point at 31 september 2010

Secondary Outcomes (2)

• 3 year recurrence free survival

  participants are followed until recurrence or time point at 31 september 2010

• Overall 3 year survival according to tumor stage, node invasion, and tumor localization

  participants are followed until death or time point at 31 september 2010

Study Arms (2)

Signet ring cell carcinoma

non signet ring cell adenocarcinoma

Eligibility Criteria

• Age: 18 Years - 95 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Intention to treat retrospective case control multicentric study, Patients will be divided into two groups (ADCI or ADNCI) depending on the presence or not of signet ring cells on definitive histologic analysis Another analysis based on chemo administration or not will be provided A pairing on demographic criteria (age, sex, ASA score, center, TNM stage and will be done to ensure comparability in case control study groups.

You may qualify if:

• All consecutive patients taken care of, for a proven histologically adenocarcinoma (ADCI and ADNCI) of the esophagus, the esogastric junction, or the stomach, in surgical or medical oncology investigator centers, will be saved in a given database.
• For whom the first consultation took place between January 1997 and January 2010
• As they benefit from a medical and/or surgical support (primitive cancer being or not resected), whatever the metastatic or the recurrence situation was.

You may not qualify if:

• Histological type other than adenocarcinoma
• Other localization than esogastric junction, esophagus or stomach

Sponsors & Collaborators

• University Hospital, Lille: lead

Study Sites (1)

University Hospital of Lille

Lille, 59037, France

Location

Related Publications (2)

• Robb WB, Messager M, Goere D, Pichot-Delahaye V, Lefevre JH, Louis D, Guiramand J, Kraft K, Mariette C; FREGATWorking Group-FRENCH. Predictive factors of postoperative mortality after junctional and gastric adenocarcinoma resection. JAMA Surg. 2013 Jul;148(7):624-31. doi: 10.1001/jamasurg.2013.63.

  PMID: 23552982 DERIVED

• Messager M, Lefevre JH, Pichot-Delahaye V, Souadka A, Piessen G, Mariette C; FREGAT working group - FRENCH. The impact of perioperative chemotherapy on survival in patients with gastric signet ring cell adenocarcinoma: a multicenter comparative study. Ann Surg. 2011 Nov;254(5):684-93; discussion 693. doi: 10.1097/SLA.0b013e3182352647.

  PMID: 22005144 DERIVED

MeSH Terms

Conditions

Carcinoma, Signet Ring Cell; Stomach Diseases

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Cystic, Mucinous, and Serous; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• christophe mariette, MD, PhD

  CHU lille

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 26, 2010
• First Posted: November 30, 2010
• Study Start: March 1, 2010
• Primary Completion: October 1, 2010
• Study Completion: December 1, 2010
• Last Updated: December 9, 2014

Record last verified: 2014-12

Locations

FR (1)